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

FDA device recall Z-2746-2011 · posted 2011-07-06 · Terminated

Recall details

Recalling firm

Stryker Instruments Division of Stryker Corporation

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.

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

MDM

Quantity affected

87 boxes, 435 untis

Distribution

Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia.

Date initiated

2011-05-27

Date posted

2011-07-06

Date terminated

2011-08-03

Location

Kalamazoo, MI