RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube i

FDA device recall Z-1851-2014 · posted 2014-06-23 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Although the Natural Rubber Latex caution symbol is clearly displayed on the product label, the accompanying caution statement "Caution: This product contains Natural Rubber Latex which may cause Allergic Reactions" was not printed on the product label.

Action taken

Teleflex Medical sent a Urgent Medical Device Recall Notification dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you have received products that are subject to this recall. We are now notifying our customers to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed above from the lot numbers listed on the attachment. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-866- 804-9881, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Error in labeling

Status

Terminated

Product code

BTR

Quantity affected

1658 ea

Distribution

Nationwide Distribution and the country of Colombia.

Date initiated

2014-05-23

Date posted

2014-06-23

Date terminated

2016-01-13

Location

Research Triangle Park, NC

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