Agency classClass IIOur severity:High FDA (Devices)·Z-2599-2015·Announced 2015-09-09

Customed Laparoscopic Cholecystectomy Kits Recalled for Sterilization Defects

Customed, Inc. is recalling 120 units of laparoscopic cholecystectomy kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the hazard is theoretical (inadequate sterilization) and no injuries or illnesses have been reported in the source text.

Plain-English summary

Customed, Inc. is recalling 120 units of the LAPAROS.CHOLE 3/CS product. This medical device is used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile.

The affected products were distributed only in Puerto Rico. The specific lot numbers involved are 141015511, 141015760, and 141216413, all with an expiration date of 10/31/15. The product code is 9001688.

Healthcare facilities and consumers should stop using these specific kits and contact the recalling firm for further instructions or replacement. The FDA has classified this as a Class II recall.

The recalled product

Product: LAPAROS.CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Manufacturer: Customed, Inc
Category: Medical Device — Surgical Kits
Hazard: sterilization-defect
package-integrity
Affected units: 120

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 170 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 170 products in this recall →

Same manufacturer · Customed, Inc

See all →

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Same hazard · sterilization defect