FDA Enforcement Class I Terminated

PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT 15" x 20" LIF (1) COVER MAYO STAND REINFORCED LIF (1) SYRINGE 1 ML WITHOUT NEEDLE LUER LOCK LIF (1) COVER TABLE REINFORCED 50" x 90" LIF (1) SYRINGE 3cc WITH NEEDLE 21 G X 1 % LIF (1) GOWN LARGE SMS NON REINFORCED TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

Recall: Z-2381-2014 · Reported September 10, 2014

Enforcement

Recall Number: Z-2381-2014
Event ID: 68536
Classification: Class I
Status: Terminated
Product Type: Devices
Firm: Customed, Inc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: September 10, 2014
Initiation Date: May 20, 2014
Classification Date: August 29, 2014
Termination Date: August 14, 2017
Address: Calle Igualdad Final #7, Fajardo, PR, 00738, United States

Description

Reason

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.

Code Info

Product code 900-1293, 7 lots: 110092130 111041087 112020325 112051676 112051745 112062348 112083385

Distribution

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.

Quantity

7 lots; 720 units (multiple units per lot)