Agency classClass IIOur severity:High FDA (Devices)·Z-1478-2016·Announced 2016-04-20

Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues

Customed, Inc. is recalling 150 Pery-Gyn Surgical Packs 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, and the hazard involves a risk-of-harm product (sterile surgical pack) where the failure of sterilization validation presents a significant risk, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Customed, Inc. is recalling 150 units of the Pery-Gyn Surgical Pack (Catalog Number 900548A). These products 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 specific lots involved are SL15176, SL15199, SL15203, SL15211, SL15259, and SL15260, with expiration dates ranging from June 30, 2016, to August 31, 2016. The agency classification for this recall is Class II.

Medical facilities and consumers should stop using these specific lots immediately and contact the recalling firm for further instructions or replacement. This recall addresses potential risks associated with the failure of the sterilization process to ensure the product is sterile as intended.

The recalled product

Product: Catalog Number: 900548A PERY-GYN SURGICAL PACK 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 Packs
Hazard: sterilization-failure
package-integrity
Affected units: 150

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 100 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 100 products in this recall →

Same manufacturer · Customed, Inc

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Same hazard · sterilization failure