—#129566

Product

Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (2) BOWL UTILITY QUART 32oz. (1) COVER MAYO STAND REINFORCED (2) MARKER SKIN WITH RULER (1) RULER (1) COVER TABLE REINFORCED 50" X 90" (2) CUP DENTURE 8oz TEAL WITH LID (6) TOWEL CLOTH HUCK BLUE (1) TUBE SUCTION CONNECT X" X 12' (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) SHEET% DRAPE REINFORCED 60" X 77" (4) DRAPE UTILITY WITH TAPE (1 0) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #1 0 CARBON STEEL (1) SYRINGE BULB 60cc (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #6.5 P/F (2) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7.5 P/F (1) SKIN STAPLE 35 WIDE (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS (2) DRAPE SIDE 42" X 76" WITH TAPE (1) DRAPE BOTIOM ABS REINFORCED 71" X 62" STD SMS WITH TAPE (1 0) GAUZE SPONGE 4" X 4" 16 PLY (1) PK. STRIP STERI CLOSURE W X 4" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: 900-3114, 2 lots: 131210804 140111438

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 #129566. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.