—#130641

Product

Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

FDA product code: MCZ — Suture Removal Kit
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot numbers 111102811 111112953 111112969 111123257 111123438 112010003 112020291 112030762 112041051 112041384 112051641 112051718 112062298 112072758 112083040 112104122 112104289 112114540 112124364 112124885 113025838 113026102 113026206 113057390 113057682 113099556 131010023 131210663 140111103 140412874 140513047 140513388 140613946 140714499 140815022

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 (QSR) 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 #130641. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.