FDA Recall Terminated

CESAREAN PACK - - (1) MAYO STAND COVER REINFORCED LIF (20) LAP SPONGES PRE-WASH XRD LIF (1) UMBILICAL CORD CLAMP LIF (1) COVER TABLE REINFORCED 50" X 90" LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) BEANNIES BABY (1) POLISHER TIP CAUTERY LIF (1) LITE GLOVE L/F (1) CAUTERY PENCIL ROCKER SWITCH L/F (1) C-SECTION DRAPE WITH POUCH LIF (1) MAYO TRAY SMALL (1) YANKAUER SUCTION TUBE WITHOUT VENT L/F (1) BLADE SURGICAL #10 CARBON STEEL (2) BOWL UTILITY 32oz. LIF (2) PAD OBSTETRICAL X- LARGE LIF (5) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41" X 58" SMS LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) EAR ULCER SYRINGE 2oz. LIF (2) GOWM IMPERVIOUS EXTRA REINFORCED X-LARGE (1) RECEIVING BLANKET 100% COTTON (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

Recall: Z-2322-2014 · Initiated May 20, 2014

Recall

Recall Number: Z-2322-2014
Event Number: 68536
Firm: Customed, Inc Calle Igualdad Final # 7
FEI Number: 2648727
Product Code: OHM
Status: Terminated
Root Cause: Package design/selection
Initiated: May 20, 2014
Posted: August 29, 2014
Terminated: August 14, 2017
Address: Fajardo, PR, 00738

Description

Reason

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Action

Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Distribution

Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.

Quantity

24 lots; 2564 units (multiple units per lot)