—#129297

Product

RETINA PACK - (1) TABLE COVER REINFORCED 44" X 78" LIF (50) COTTON TIP APPLICATOR 6" WOOD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (2) MEDECINE CUP 2oz LIF (5) TOWELS ABSORBENT 15" X 20" LIF ( 1) UNIVERSAL EYE SHIELD (1) EYE DRAPE (1) BIPOLAR CABLE DISPOSABLE ( 1) OPHTALMIC BIPOLAR PENCIL (10) GAUZE SPONGE 4" X 4" 16PLY (2) EYE PAD 2 1/8 X 2 5/8 ST. ( 1) MAYO STAND COVER REINFORCED LIF ( 1) KNIFE 15 5.0 CONTROLLED DEPTH. (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) SURGICAL BLADE #15 STAINLESS STEEL (3) SYRINGE 1CC TUBER. 25G X 5/8 SLIP TIP L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA product code: OJK — Eye Tray
Device class: Class 2
Medical specialty: Ophthalmic
Affected lot / code info: Product code 900-1611, 10 lots: 111123361 112030624 112051849 112072779 112114640 112124965 113078268 113088833 140412455 140513000

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 #129297. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.