Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22 2 Prep ChloraPrep One-Step 3 1 Dressing Transparent 4 X 4 1 Glove Perry 6.5 PF Steril 1 Bowl Fluid Containment W/Li 1 Cover backtable 50 X 90 Zon 1 Cup medicine 2 oz clear 2 Stopcock 3 way rot m/l/l 2 Needle RB 22x 1.5 1 Spike B
Hazard
Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
What You Should Do
On March 26, 2021, Windstone Medical Packaging dba Aligned Medical Solutions issued a "Urgent Medical Device Recall notification to affected consignees via US Mail. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Due to the manufacturing process and finished sterilized packs, if any, in inventory, or at your facility, over labeling of inventory affected by this recall will be labeled with a sticker attached to each pack. The sticker will read: "Recall Notice Smith Medical announced the recall of the angio tubing contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall, 1. At the time the kit is opened for use any angio tubing manufactured by Smith Medical should be identified and set aside, 2 The recalled tubing should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. 2. Please complete the attached AMS recall reply form and return it to Aligned Medical Solutions at the Fax number provided on the form. If you do not have the affected product you must complete and return the AMS Recall Reply Form. replacement product will be issued upon request and completion of the attached Recall Reply For. 3 If you have any questions or concerns, please contact Vicki Davis, Quality Manager, 407-638-9924
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Products
- Brand
- Windstone Medical Packaging, Inc.
- UPC
- Lot Number 146304 and 147534
Units Affected
114 units