—#129306

Product

OPHTALMIC PACK - (1) GOWN LGE SMS NON REINF TIWRAP (1) IODINE POVIDONE 1oz. (2) TOWEL ABSORBENT 15" x 20" UF (1) SYRINGE 3cc W/NEEDLE 21 G X 1 Y. UF (6) COTION TIP APPLICATOR 6" WOOD (1) TABLE COVER REINFORCED 50" X 90" UF (1) PAD EYE 2 1/8 X 2 5/8 (1) CYSTOTOMO IRRIG. PEARCE 25G X 5/8 (1) SHIELD EYE UNIVERSAL (1) Pr. GLOVES SURG.# 7% LATEX (10) SPONGE EYE SPEAR MICRO (1) SYRINGE 1cc TUBER. 25G X 5/8 SITIP UF (10) GAUZE SPONGES 4" X 4" 12PL Y (1) Pr. GLOVES SURG. 8 POWDER LATEX (1) MAYO STAND COVER REINFORCED UF (1) BLADE 15D WITH HANDLE (STABKNIFE) (1) EYE DRAPE (1) GOWN LARGE STANDARD SMS (1) TRAY 3/COMPART (1) BAG ZIP LOCK (1) ANGLED FULL HANDLE (1 ) Pr. GLOVES SURGICAL# 6% LATEX 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 900-1780, 25 lots: 112010094 112020415 112041205 112051885 112072786 112083376 112083453 112104301 112114612 112125037 113015436 113036758 113057839 113068042 113078279 113088764 113099281 113109757 131110203 131110602 140111178 140211654 140312436 140513114 140513454

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 #129306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.