—#130654

Product

Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA product code: FYA — Gown, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers: 111103265 111113126 112010183 112020505 112030804 112041056 112051993 112072804 112093631 112104361 112104533 112124897 113026196 113036804 113057491 113067873 113078333 113088873 113099438 113109852 131110265 131210654 140111126 140211540 140312173 140312384 140513370 140714295 140814813 140814957 140915481

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 #130654. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.