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.
Recall
- Recall Number
- Z-2746-2011
- Event Number
- 58907
- Firm
- Stryker Instruments Division of Stryker Corporation
- FEI Number
- 1811755
- Product Code
- MDM
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- May 27, 2011
- Posted
- July 6, 2011
- Terminated
- August 3, 2011
- Address
- 4100 East Milham Ave., Kalamazoo, MI, 49001
Description
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.
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.
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.
Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia.
87 boxes, 435 untis