Mold Hazard

Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.

Firm received sporadic reports of discoloration on certain lots of the product, which has been identified as common mold.

On August 30, 2018, Medline sent Immediate Action Required letters to all of their consignees. Each letter was accompanied by an Urgent Remedial Action Destruction Form which was to be completed and returned to the firm.

SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin.

A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).

Customers were notified of the recall via Urgent: Voluntary Medical Device Recall letters on approximately 10/26/2017. The letter identified the affected device and the reason for the recall. The letter also provided instructions for distributors, retailers, and end users. End Users are to 1.) Inspect all shippers of 411802 (Durahesive), and all loose market units of 411803 (Stomahesive) to confirm whether affected product is under their control; 2.) Perform a count of affected product currently in inventory and complete and return the enclosed response form to the address provided; 3.) If customers have any affected product in inventory they are to contact cic@convatec.com or call the Customer Interaction Center at the toll free number 1-800-422-8811 for further instructions regarding how to return affected product and receive correctly labeled replacement product.

Roof Moldings May Detach

A detached roof molding could become a road hazard, increasing the risk of a crash.

Dealers will inspect and replace, or secure the roof moldings, as necessary, free of charge. Owner notification letters were mailed March 30, 2023. Owners may contact Hyundai customer service at 1-855-371-9460. Hyundai's number for this recall is 241.

Mirror May Detach and Become Road Hazard

A molded hood mirror that falls into the roadway can become a road hazard, increasing the risk of a crash.

Dealers will inspect for a wire harness or tether and replace the hood mirror assembly as necessary, free of charge. Owner notification letters are expected to be mailed February 14, 2023. Owners may contact Peterbilt's customer service at 1-940-591-4220. PACCAR's number for this recall is 22PBF.

Evaporator coil drain pans Recalled for Fire Hazard

The molded plastic drain pan located at the bottom of the evaporator coil can overheat, melt and deform, posing a fire hazard.

Consumers should contact Daikin Comfort Technologies Manufacturing, L.P. (DCT) to determine whether your unit is included in this recall and to register for the free repair by a qualified technician. DCT is contacting all registered consumers where records indicate their gas furnace system is subject to the expanded recall.

Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ (10 mL) tubes, UPC Code 860002022116

Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.

Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Root), Dosage: 1 capsule up to 3 times per day day at 450mg Kava root. 90 counts per bottle. UPC 7 48840 14284 8. Kava Capsules older lots are packaged in 250cc Wide Mouth Amber Glass Packer, Black 45/400 PP ribbed skirt screw-top lid, clear neck band, Wise Woman Herbals Large botanical label. Kava Capsules newer lots are packaged in White polypropylene packer style bottle, White serrated flat-topped lid with foam liner, clear neck

The microbial test result is found to be out of specification due to high yeast and mold counts.

EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

Bard Peripheral Vascular, Inc. (BPV) mailed a recall letter on May 23, 2019 to each of the US consignees via FedEx with proof of delivery notification. BPV is also issuing customer notifications for product outside the US in accordance with regulations of each country in which the product was distributed. The recall letter asked consignees to do the following: 1. Do not use or further distribute any affected product. 2. Please check all inventory locations within your institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from your shelves. 4. If you have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from your inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important that we receive this information. 6. Please call our BPV Customer Support Center at 1-800-321-4254 Option #5 (M-F 5am to 2pm MST) or email at BDPI.CustomerSupportCenter@bd.com. Once all information has been verified, the BPV Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. BPV will issue a replacemnt product for your returned product. 7. Email the completed Recall and Effectiveness Check Form to BDPI.CustomerSupportCenter@bd.com or fax it to BPV at 1-800-994-6772. If you cannot email or FAX the form, please call the BPV Customer Support Center at 1-800-321-4254 Option #5 and report the required information verbally. 8. A mailing labe

ZOCALO AJI LIMO DRIED CHILI PODS- ORGANIC, Dried Aji Peppers for consumer consumption. Product is vacuum sealed in plastic bag. Net weight per bag 1.25 oz (35 g), 6 bags per case. Product of Peru. UPC 8 32924 00879 0. The product label is read in parts: "***ZOCALO gourmet *** ORGANIC AJI LIMO ***The Aji limo chili is a spicy yet sweet traditional Peruvian ingredient often used a based with sautee onions, garlic and herbs ***PRODUCT OF PERU *** Produced by: AgroExport Topara SAC, Chincha, Peru

Due to presence of mold on product

happi foodi , Roasted Russets and Asparagus, 10 oz frozen bowl, 8 packages per case, Keep Frozen DOM- 05/20/2021

Presence of visible mold detected.

Dr. Berg Nutritionals, Liquid Vitamin D with Zinc Dietary Supplement ( Liquid Vitamin D ), Individual 1 FL OZ bottle (with no secondary packaging), Glass bottle. The label of the Liquid Vitamin D product includes the following storage instructions: Store in a cool, dark place, with a lid.

Product recalled because of the presence of mold and/or yeast found in amounts that exceed the product's established specifications .

Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.

Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8.

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 00614 1); b) 50 mL Net Content 1.69 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 7); c) 118 mL Net Content 4 oz bottle, (UPC 8 52379 00634 9 and 8 52379 00612 9); d) 236.58 mL Net Content 8 oz bottle, (UPC 8 52379 00635 6); e) 250 mL Net Contents 8.45 oz (UPC 8 52379 00611 0); f) 300 mL Net Content

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

Luer Lock Set - Catalog # MPC-125, for IV administration sets.

Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrectly labeled as Molded Products Male to Male Luer Adapters, Catalog # MPC-150.

On June 10, 2019, the firm sent URGENT MEDICAL DEVICE RECALL letters to their consignees advising them of the labeling problem, requesting that they check their stock, notify their end users and complete the attached MEDICAL DEVICE RECALL CUSTOMER RESPONSE FORM.

REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

On 03/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL " Letter via Stericycle, Inc. informing customers that it has identified the potential for certain lots of Spiros to exhibit small amounts of leaks due to a molding defect. Customer are instructed to: 1) Discontinue the use and distribution of the affected product immediately. Check their inventory and quarantine all affected product at their facility. 2) Inform potential users of the product in their organization of this notification and complete the attached response form. Return the completed response form to the fax number or e-mail address on the form, even if the customer does not have the affected product. 3) The Recalling Firm has some lots of unaffected product available today and is actively increasing the amount of available inventory. Please contact customer service for product availability. 4) Return affected product using the return label provided with this letter. Contact Stericycle at 1-866-300-2207 (MF, 8am-5pm ET) if customers have not received a return label or require additional labels for returning the affected product. The return labels are for single use only. Do not reproduce. Customers can visit http://expertezlabel.com to request additional labels for returning affected product. To ensure proper and timely credit, follow the instructions on the return label for returning product. Upon receipt of the completed response form and return of the affected product, the Recalling Firm will credit customers for any product returned. Customers will only receive credit for product that are returned. NOTE: Credits for product purchased through distributor will be credited by the distributor. 5) If customers have distributed the product further, immediately notify those accounts that received the product identified in the Affected Product / Table 1 sections of this notification and ask them to contact Stericycle at 1-866-300-2207 (M-F, 8am-5pm ET) to obtain a response form. For

The Toasted Oat Bakehouse Cherry Streusel Soft Granola (6 - 10oz pouches per case); and Soft Granola Crumble Bars Cherry Streusel ( 5 - 28.3g bars per pack/6 packs per case)

Ingredient containing mold was used in production

The Toasted Oat Bakehouse Macadamia Chunk Soft Granola (6 - 10oz pouches per case); and Soft Granola Crumble Bars Macadamia Chunk ( 5 - 28.3g bars per pack/6 packs per case).

Ingredient containing mold was used in production