Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound

FDA device recall Z-0292-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Customed, Inc

Reason for recall

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.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

LRO

Quantity affected

315

Distribution

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

Date initiated

2014-10-08

Date posted

2014-12-16

Date terminated

2017-08-14

Location

Fajardo, PR