Agency classClass IIOur severity:High FDA (Devices)·Z-2690-2015·Announced 2015-09-09

Customed Laparoscopy GYN PK CS/4 Recalled for Sterilization Validation Issues

Customed, Inc. is recalling 112 units of Laparoscopy GYN PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

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 is classified as FDA Class II. The hazard involves inadequate sterilization validation, which poses a risk of infection or harm, but the source does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Customed, Inc. is recalling 112 units of the Laparoscopy GYN PK CS/4 product. These kits are 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 recall involves specific lots with the following codes and expiration dates: Lot 141015722 (exp. 10/31/15), Lot 150116814 (exp. 1/31/16), and Lot 150217426 (exp. 2/28/16). The product code is 900605.

Healthcare facilities and consumers should stop using these specific lots immediately. The FDA has classified this as a Class II recall, indicating that use of or exposure to the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product: LAPAROSCOPY GYN PK CS/4 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-failure
infection-risk
Affected units: 112

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

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Same hazard · sterilization failure