The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2406-2014·Announced 2014-09-10

Customed Recalls PERY GYN PACK Surgical Drapes Due to Packaging Integrity Concerns

Customed, Inc. is recalling PERY GYN PACK surgical drapes 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 53 lots of PERY GYN PACK surgical convenient packs. The product consists of EO sterilized surgical drapes, towels, and legging components packaged in polyester/polyethylene breather bags with Tyvek double vents. The recall involves 1,800 units distributed worldwide, including the United States (nationwide, Florida, Puerto Rico, USVI), Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico.

The recall was initiated because Customed determined there is a possibility that packaging integrity may be compromised on different catalog numbers. This defect could result in product contamination or a loss of sterility condition, which poses a risk of injury to patients.

Healthcare facilities and distributors should stop using the affected lots immediately. The specific lot numbers are listed in the agency's recall record Z-2406-2014. Users should contact Customed, Inc. for instructions on returning or disposing of the recalled products.

The recalled product

Product
PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1 ) TABLE COVER REINFORCED 50" X 90" UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged…
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Drapes
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 900-1716

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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