Agency classClass IIOur severity:High FDA (Devices)·Z-2605-2015·Announced 2015-09-09

Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies

Customed, Inc. is recalling 104 units of Cesarean Packs 4/CS 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 involves a risk-of-harm product (sterile surgical packs) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported in the source text.

Plain-English summary

Customed, Inc. is recalling 104 units of the Cesarean Pack 4/CS. These medical device packs 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 covers four specific lots with the following codes and expiration dates: 140915239 (exp. 10/31/15), 141015732 (exp. 11/30/15), 150116697 (exp. 1/31/16), and 150418265 (exp. 4/30/16). The product code is 9001719.

Healthcare facilities and consumers should stop using these specific lots immediately. The source text does not provide specific instructions for disposal or return, but users should contact the recalling firm or their local health authority for guidance on how to handle the recalled items.

The recalled product

Product: CESAREAN PACK 4/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 Packs
Hazard: sterilization-defect
package-integrity
Affected units: 104

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 defect