FDA Medical Device Recalls (openFDA)
Cardinal Health: 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 Healthcare Corporation, McGaw Park, IL 60085 USA
- Recall number
- Z-0420-03
- Recalling firm
- Cardinal Health
- Product
- 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 Healthcare Corporation, McGaw Park, IL 60085 USA
- Status
- Terminated
- Initiated
- 2002-11-15
- Posted
- 2003-01-09
- Terminated
- 2006-04-14
- Reason
- Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.
- Root cause
- Other
- Action
- 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.
- Quantity
- 232,228 trays
- Distribution
- Nationwide distribution, including Puerto Rico and Guam, and internationally to Saudi Arabia
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GCB--
- Firm FEI
- 3001236905
- Firm city
- McGaw Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28