—#130651

Product

Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA product code: NWO — Kit, Catheter, Urinary (Exludes Hiv Testing)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Lot numbers: 111113096 111123429 112020157 112020479 112030817 112041410 112051447 112062453 112072960 112083428 112093754 113067870 113068167 113088807 113099431 131110259 131210687 140111124 140211538 140412668 140613604 140714264 140814790 140915160

Why it was recalled

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

Root cause (FDA determination)

Packaging

Action the firm took

Customed initiated a recall on October 8th, 2014 of sterile convenience surgical Packs-trays, bags (known as Convenience Packs) and new lots of products added to the initial June 3, 2014 recall of 233 sterile surgical packs. The products are being recalled because of significant compromised sterility, not limited to potentially damaged packaging. Customers were instructed to quarantine and cease use of the affected product identified. Customers are to return the response form included with the letter, to the contact information provided. Upon receipt, the firm will contact customers with further instructions to obtain credit, replacement product, and for return of the recalled product or any other disposition action. If customers have any questions, they should contact the Customed Recall Coordinator at 407-850-5558 extensions 8001 or 8005, or via e-mail: pablo.diaz@customedhealing.com.

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: US Distribution to Florida, New York and Puerto Rico..

Timeline

Recall initiated: 2014-10-08
Posted by FDA: 2014-12-16
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130651. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.