—#129247

Product

LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML LIF (1) BLADE SURGICAL# 10 CARBON STEEL (5) LAP SPONGE PREWASH 18" X 18' XRD LIF (6) TOWELS ABSORBENT 15" X 20" LIF ( 1) CAUTERY TIP POLISHER L/F (2) UTILITY BOWL 16oz LIF (1) TUBE SUCTION CONNECT%" X 12' LIF (2) NEEDLE & BLADE COUNTER 10c MAG /CLEAR LIF (1) DRAPE T LAPAROTOMY 102" X 78" 121" SMS STD LIF ( 1) SPECIMEN CONTAINER 4oz WITH LID & LABEL ( 1) YANKAUER SUCTION TUBE WITHOUT VENT LIF ( 1) TIME OUT BEACON NON WOVEN LIF ( 1) GOWN SURG. REINFORCED XLGE TOWEL & WRAP LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA product code: FHI — Ring, Laparotomy
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Product code 900-848, 23 lots: 112041259 112072813 112072916 112114685 112124855 112125308 113015569 113047034 113047207 113057642 113067938 113068189 113078590 113099301 113109648 113109876 131110346 140111253 140211856 140312186 140412473 140513146 140513482

Why it was recalled

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-05-20
Posted by FDA: 2014-08-29
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129247. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.