Z-0420-03

Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free...

Name: Z-0420-03 Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free...
Creator: Cardinal Health
Published: 2002-11-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2002-11-15 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health began a recall of Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis... on 2002-11-15. The reason FDA records is "Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0420-03
Status: Terminated
Initiated: 2002-11-15
Posted: 2003-01-09
Terminated: 2006-04-14
Recalling firm: Medtronic, Inc.
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
Product code: GCB--
Reason for recall: Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 232,228 trays
Distribution: Nationwide distribution, including Puerto Rico and Guam, and internationally to Saudi Arabia
Product codes and lots: 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.

Product code GCB--

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)