The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0294-2015·Announced 2014-12-10

Customed ENT Packs Recalled for Compromised Sterility and Contamination Risk

Customed, Inc. is recalling 140 ENT Packs due to compromised sterility and manufacturing deficiencies that 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 140 units of the ENT Pack, Catalog number 900-1482. These medical devices are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are distributed in Florida, New York, and Puerto Rico.

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

The affected lot numbers are 140513090, 140613609, 140714182, and 140814653. Medical facilities and consumers should stop using these products and contact the manufacturer for further instructions.

The recalled product

Product
ENT Pack, Catalog number 900-1482. 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 Packs
Hazard
Affected units
140

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)

  • Lot numbers 140513090 140613609 140714182 140814653

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 →

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