PlainRecalls
FDA Devices Critical Class I Terminated

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) SURGI

Reported: September 10, 2014 Initiated: May 20, 2014 #Z-2403-2014

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Customed, Inc
Units Affected
10 lots; 336 units (multiple units per lot)
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.
Location
Fajardo, PR

Frequently Asked Questions

What product was recalled?
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.. Recalled by Customed, Inc. Units affected: 10 lots; 336 units (multiple units per lot).
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 10, 2014. Severity: Critical. Recall number: Z-2403-2014.