Customed Labor and Delivery Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 344 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly states that the compromised sterility and contamination risks 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects.
Plain-English summary
Customed, Inc. is recalling 344 units of the Labor & Delivery Pack, catalog number 900-419. These medical packs are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are identified by lot numbers 140211670, 140311939, 140613759, and 140714547.
The recall was initiated because of significant compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions have increased the risk of contamination. These conditions may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities that have received these products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Labor & Delivery Pack, Catalog number 900-419. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 344
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)
- Lot numbers 140211670 140311939 140613759 140714547
Distribution
Part of a larger recall action
This product is one of 179 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.
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