Events

Recall of Device Recall Pharmaseal Thoracentesis Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25054
  • Event Risk Class
    Class 2
  • Event Number
    Z-0420-03
  • Event Initiated Date
    2002-11-15
  • Event Date Posted
    2003-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25087
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code GCB--
  • Reason
    Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.
  • 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.

Device

Device Recall Pharmaseal Thoracentesis Tray
  • Model / Serial
    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 Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution, including Puerto Rico and Guam, and internationally to Saudi Arabia
  • Product Description
    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
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, ATTN: V. MUELLER QA, McGaw Park IL 60085
  • Source
    USFDA