Recall Z-2746-2011 ยท MDM Instrument, Manual, Surgical, General Use
Stryker Instruments Division of Stryker Corporation
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.
| Date | Jul 6, 2011 (initiated May 27, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 87 boxes, 435 untis |
| Distribution | Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.