Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage; Allegiance Healthc
Hazard
Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.
What You Should Do
Recall letters dated 11/15/02 were sent via 2-day FedEx to the direct accounts. The accounts were informed of the potential for breakage of the catheters during use, requested to inspect their inventories for the affected lot numbers, and segregate any found for return to Allegiance for replacement. Distributors were requested to sub-recall the product from their accounts. The recall was extended to include the 21 additional lots by letter dated 4/8/04. The letters were sent via Airborne Express, 1-Day, on 4/8/04. The instructions were the same as the 11/15/02 letter, except that Allegiance has changed their name to Cardinal Health.
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Products
- Brand
- Cardinal Health 1430 Waukegan Rd ATTN: V. MUELLER QA McGaw Park IL 60085
- UPC
- L1J035X, L1J088, L1K042, L1K058, L1K070, L1L057X, L1N018, L1N031, L1N039X, L1N094, L1P017, L1P045, L1S015, L2A012, L2A021, L2A048, L2A075, L2B039, L2B047 ,L2B073, L2C012, L2C038, L2C083, L2D041, L2D067, L2E036 The recall was expanded on 4/8/04 to include the following additional lots: L1J072, L2D102X, L2H001, L2H007, L2J004, L2J021, L2J088, L2K001, L2K021, L2L026, L2L037, L2N022, L2N085, L2P113, L2S123X, L2S128, L2S166, L2S185, L3A105, L3A218X, L3A224.
Units Affected
232,228 trays