Agency classClass IOur severity:Severe FDA (Devices)·Z-0349-2015·Announced 2014-12-10

Customed Laparotomy Packs Recalled for Sterility Compromise and Contamination Risk

Customed, Inc. is recalling 64 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause 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: "Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in…"

Plain-English summary

Customed, Inc. is recalling 64 units of Laparotomy Packs, catalog #900-2516, lot number 140814782. These medical supplies are used by staff for patient care procedures such as wound healing, suture removals, and wound irrigation.

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

The affected products were distributed in the United States to Florida, New York, and Puerto Rico. No specific dates or additional distribution details are provided in the source text.

The recalled product

Product: Laparotomy Pack, catalog #900-2516 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 Supplies
Hazard: contamination
infection
Affected units: 64

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 140814782

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