The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2501-2014·Announced 2014-09-10

Customed Recalls Surgical Gown Packs Due to Packaging Integrity Concerns

Customed, Inc. is recalling EO sterilized surgical gown packs 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 1,500 units of Gown Surgical Soft SMS Non Reinforced, code 900-2725. The product consists of EO sterilized surgical convenient packs containing a gown, towel, and wrapper, packaged in a polyester/polyethylene breather bag with Tyvek double vents. The recall involves two specific lots with codes 112093989 and 113057519.

The recall was initiated because Customed determined 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.

The affected products were distributed worldwide, including nationwide in the United States (specifically Florida, Puerto Rico, and the US Virgin Islands) and in the countries of Tortola, Trinidad, Dominican Republic, Costa Rica, and Mexico. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE (1) TOWEL ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with…
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Supplies
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)

  • Code 900-2725: 2 lots 112093989 113057519

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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