Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile urine collection device that collects urine by me

FDA device recall Z-1158-2013 · posted 2013-04-22 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Sterile packaging may be compromised.

Action taken

Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 28, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you have any of the affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed. If you and your customers have no affected stock please complete the enclosed Recall Acknowledgement Form and fax it to 1 (866) 804-9881 Attn: Customer Service. This will allow us to document your receipt of this letter. 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. If you have any other questions feel free to contact your local sales representative or Customer Service at 1 (866) 246-6990.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KNX

Quantity affected

190,103

Distribution

Worldwide Distribution - USA and the countries of Singapore, Canada, New Zealand, Germany, Ireland, Japan and Australia.

Date initiated

2013-03-28

Date posted

2013-04-22

Date terminated

2014-05-01

Location

Durham, NC