Agency classClass IIOur severity:High FDA (Devices)·Z-2559-2015·Announced 2015-09-09

Customed OB Packs Recalled for Sterilization Validation Deficiencies

Customed, Inc. is recalling 96 OB Packs CS/4 in Puerto Rico due to inadequate sterilization validation 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 potential sterility failure in a medical device used for surgical procedures, which poses a risk of harm, but the source does not report specific hospitalizations or injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Customed, Inc. is recalling 96 packs of OB PACK CS/4, a medical device used by staff for surgical procedures and patient care such as wound healing and suture removals. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as issues with package integrity for products released as sterile.

The affected products were distributed only in Puerto Rico. The specific lots involved are 141015753 and 140915228, both with an expiration date of 10/31/15. The product code is 9001030.

This recall is classified as Class II by the FDA. Medical facilities and consumers should stop using these specific lots and contact the manufacturer for further instructions.

The recalled product

Product: OB PACK 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 Instruments
Hazard: sterility-failure
infection-risk
Affected units: 96

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)

Code: 9001030 Lots: 141015753 exp. 10/31/15 140915228 exp. 10/31/15

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 · sterility failure