—#129265

Product

ARTHROSCOPY PACK- (1) VIDEO CAMERA DRAPE 13cm X 244cm LIF (2) BANDAGE ELASTIC 6" X 5yrd. LIF (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) DURAPREP SURGICAL SOLUTION 26m I LIF (1) STOCKINETIE IMPERVIOUS (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF (1) BAG SUTURE FLORAL LIF (1) BLADE SURGICAL #11 CARBON STEEL (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (1) SYRINGE 30cc SLIP TIP LIF (1) TABLE COVER 44" x 90" (1) MAYO STAND COVER REINFORCED LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD UF (1) DRAPE SHEET 41 " x 58" SMS UF (1) NEEDLE HYPODERMIC 22G X 1 Y:z (1) NEEDLE HYPODERMIC 18G X 1 Y:z (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (10) GAUZE SPONGES 4" X 4" 16PL Y EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA product code: FWZ — Operating Room Accessories Table Tray
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Product code 900-1062, 16 lots: 109071569 112072765 112083154 113057380 113057684 113057854 113078233 113078670 113089154 113099586 131110151 131110593 131210956 140412452 140513063 140513390

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 #129265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.