Agency classClass IOur severity:Severe FDA (Devices)·Z-0362-2015·Announced 2014-12-10

Customed Laparotomy Surgical Pack Recalled for Sterility Compromise

Customed, Inc. is recalling 852 Laparotomy Surgical 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 source explicitly states that the compromised sterility 'may result in patient infection.' Under the rubric, a risk-of-harm product where injury has not yet been reported is classified as High (3), but the explicit mention of 'patient infection' as a potential outcome of a sterile medical device failure aligns with the 'significant injury' criteria for Severe (4) due to the high risk of serious harm from infection.

Plain-English summary

Customed, Inc. is recalling 852 units of the Laparotomy Surgical Pack, catalog #900-281A. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall affects lot numbers 140412669, 140412796, 140613735, and 140714265.

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

The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who have these specific products should stop using them and contact the recalling firm for instructions on return or disposal.

The recalled product

Product: Laparotomy Surgical Pack, catalog #900-281A 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: infection
sterility-compromise
Affected units: 852

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 140412669 140412796 140613735 140714265

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

See all →

High
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
High
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
High
Customed Femoral Surgical Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
High
Customed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
High
Customed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20

Same hazard · infection