PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINF. LIF (3) ABSORBENT TOWEL 15" x 20 LIF (2) EYE PAD 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR MICRO SPONGE VELCRO/NECK EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product code 900-1156, 12 lots: 109122834 110010026 110020379 110020559 110040869 110041086 110051182 110061483 110071624 110081995 110092119 110102582
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Customed, Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINF. LIF (3) ABSORBENT TOWEL 15" x 20 LIF (2) EYE PAD 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR MICRO SPONGE VELCRO/NECK EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-1156, 12 lots: 109122834 110010026 110020379 110020559 110040869 110041086 110051182 110061483 110071624 110081995 110092119 110102582
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2376-2014
Related Recalls
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.