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

FDA device recall Z-0420-03 · posted 2003-01-09 · Terminated

Recall details

Recalling firm

Cardinal Health

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GCB

Quantity affected

232,228 trays

Distribution

Nationwide distribution, including Puerto Rico and Guam, and internationally to Saudi Arabia

Date initiated

2002-11-15

Date posted

2003-01-09

Date terminated

2006-04-14

Location

McGaw Park, IL