Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2746-2011

Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER...

Stryker Corp. / initiated 2011-05-27 / Terminated / root cause: manufacturing process

Stryker Instruments Division of Stryker Corporation began a recall of Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700... on . The reason FDA records is "The towel clamps packaged with the wire caddy have been found to have blood stains on them which could result in infection or blood borne pathogen transmission". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2746-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
Product
Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210. This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter.
Product code
MDM Instrument, Manual, Surgical, General Use
Reason for recall
The towel clamps packaged with the wire caddy have been found to have blood stains on them which could result in infection or blood borne pathogen transmission.
Root cause tag
manufacturing process
FDA root cause
Material/Component Contamination
Action
Stryker Instruments sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to quarantine affected product and return the recalled product using the shipper supplied to them by Stryker. Replacements will be issued to customers upon receipt of the product. For questions regarding this recall please call 1-800-800-4236 ext. 3808.
Quantity in commerce
87 boxes, 435 untis
Distribution
Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia.
Product codes and lots
Lots 10306012, 10323012, 10340022, 11007012 and 11047012