Recall Z-0094-2011

Codman & Shurtleff, Inc. · initiated July 16, 2010

Terminated

Product

Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399

Codes / lots: Lot numbers: EB514 FB465 GB498 GB449 HB544 HB545 KB438 KB538 KB436 KB527 LB554 LlB555 AC464 421417 421418 421419 422512 423826 423076 423827 423828 423829 423830 423075 HB499

Reason for recall

Surgical Pattie x-ray stripe (radio-opaque marker) became detached

FDA-determined cause: Process control

Action taken

Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460.

Details

Recall number
Z-0094-2011
Initiated
July 16, 2010
Posted by FDA
October 20, 2010
Terminated
July 9, 2012
Product code
HBA – Neurosurgical Paddie
Quantity
4407 boxes (20 pouches of 10 patties)
Distribution
Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
Recalling firm
Codman & Shurtleff, Inc., Raynham, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0093-2011 Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code:…Surgical Pattie x-ray stripe (radio-opaque marker) became detached 07/16/2010Terminated
Z-0095-2011 Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties…Surgical Pattie x-ray stripe (radio-opaque marker) may become detached 07/16/2010Terminated