The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2376-2014·Announced 2014-09-10

Customed Recalls PHACO PACK Surgical Kits Due to Packaging Integrity Concerns

Customed is recalling 1,775 units of PHACO PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

Customed, Inc. is recalling 1,775 units of PHACO PACK surgical kits across 12 lots. The recall is due to a determination that packaging integrity may be compromised on different catalog numbers. The affected product is an EO sterilized surgical convenient pack packaged into a polyester/polyethylene breather bag with Tyvek double vents.

The compromised packaging integrity could result in product contamination or loss of sterility condition, which poses a risk of injury to patients. The recall covers 12 specific lots with product code 900-1156.

The affected products were distributed worldwide, including nationwide in the United States (specifically noting Florida, Puerto Rico, and USVI) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Healthcare facilities and consumers should stop using the affected lots and contact Customed for instructions on return or replacement.

The recalled product

Product
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…
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Kits
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Product code 900-1156

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 233 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 233 products in this recall →

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