Customed Labor and Delivery Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 352 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may result in 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 recall involves a medical device with compromised sterility that may result in patient infection, meeting the criteria for a Severe (Score 4) classification due to significant injury risk.
Plain-English summary
Customed, Inc. is recalling 352 units of the Labor & Delivery Pack, Catalog number 900-168. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination and may result in patient infection.
The affected products were distributed to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140513102, 140513461, 140714196, 140814534, 140814736, and 140814972. Medical facilities should stop using these products and contact the recalling firm for instructions.
The recalled product
- Product
- Labor & Delivery Pack, Catalog number 900-168. 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
- 352
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 140513102 140513461 140714196 140814534 140814736 140814972
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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