—#130653

Product

Surgeon Reinforced Gown XL, Catalog number 900-521. 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: 111103264 112010182 112020504 112030803 112041055 112051992 112062557 112062558 112072803 112093630 112104254 112104360 112114532 112114896 112125100 113026195 113036464 113036803 113057608 113057848 113068173 113088872 113089076 113109851 131210264 131210653 140111125 140211539 140312172 140312383 140513369 140714294 140714515 140814956 140915480

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 #130653. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.