Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause al

FDA device recall Z-0464-2014 · posted 2013-12-06 · Terminated

Recall details

Recalling firm

Centurion Medical Products Corporation

Reason for recall

Package labeling indicates both "latex free" and "contains natural rubber latex" . The rubber bands do contain natural rubber latex. This could cause a significant risk to users with latex allergies.

Action taken

Centurion sent a Urgent Recall Notification letter via Certified Mail October 31, 2013, return receipt to all affected customers. The affected Centurion Medical Products Corporation sales representatives were notified via email on October 28, 2013. Customers were instructed to destroy all implicated product and complete the accountability record included with the notice and fax to 517-546-3356. Customers were asked to forward a copy of the notice if product was further distributed. Additional notices will be mailed to non-responsive customers via Certified Mail Return Receipt, and will be documented in the recall file. For further questions please call (517) 546-5400.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

LDQ

Quantity affected

500 lots

Distribution

US Distribution including the states of GA, LA and NY.

Date initiated

2013-10-28

Date posted

2013-12-06

Date terminated

2014-01-29

Location

Howell, MI