Agency classClass IOur severity:Severe FDA (Devices)·Z-0245-2015·Announced 2014-12-10

Customed Surgeon Gowns Recalled Due to Compromised Sterility and Contamination Risk

Customed, Inc. is recalling Surgeon Reinforced Gowns XL because compromised sterility and manufacturing deficiencies may result in patient infection.

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 products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk…"

Plain-English summary

Customed, Inc. is recalling Surgeon Reinforced Gown XL, Catalog number 900-521, due to compromised sterility. The recall includes 89,284 units distributed to Florida, New York, and Puerto Rico. The product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.

The recall is being conducted because of serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions. These issues increase the risk of contamination, which is not limited to potentially damaged packaging, and may result in patient infection.

Medical facilities and consumers should stop using the affected gowns immediately. The specific lot numbers subject to the recall are: 111103264, 112010182, 112020504, 112030803, 112041055, 112051992, 112062557, 112062558, 112072803, 112093630, 112104254, 112104360, 112114532, 112114896, 112125100, 113026195, 113036464, 113036803, 113057608, 113057848, 113068173, 113088872, 113089076, 113109851, 131210264, 131210653, 140111125, 140211539, 140312172, 140312383, 140513369, 140714294, 140714515, 140814956, and 140915480.

The recalled product

Product: Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Gowns
Hazard: contamination
infection
Affected units: 89,284

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 179 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 179 products in this recall →

Same manufacturer · Customed, Inc

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Same hazard · contamination