Dialysis Tray, SP560, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI
FDA Recall Z-1938-2010 · Posted 2010-06-30
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Recalling FirmCenturion Medical Products
Recall StatusTerminated
Product CodeFKG
Date Initiated2010-03-16
Date Terminated2011-02-09
Product Quantity144 kits
Reason for Recall
The 3M micropore tape is under recall due to the tape not performing and needles becoming loose and dislodged.
Firm Action
The firm sent Urgent Recall Product Notices to its two customers dated 3/16/2010. The letter explained that the tape may not adhere properly. The consignees were instructed to remove any kits containing the recalled tape from their inventory, if the tape was used to secure dialysis needles or pressure dressings. If the tape was used for other purposes, the kits could still be used. The recall letter included a reply form for customers to complete and email or fax back. Upon receipt of the form, a Centurion Representative will contact them to retrieve affected product. Customers should contact Matthew Price at 517-546-5400 ext. 1135, if further info is needed.
Root Cause
Other
Distribution Pattern
Nationwide Distribution -- AR and OH.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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