Customed Premium Laparotomy Pack Recalled for Compromised Sterility
Customed, Inc. is recalling Premium Laparotomy 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 source explicitly states that the recall is due to compromised sterility which 'may result in patient infection.' Under the severity rubric, a risk of harm where injury has not yet been reported is classified as High (3), but the explicit mention of 'serious deficiencies' and the potential for 'patient infection' in a sterile medical context aligns with the criteria for Severe (4) regarding significant injury reports or high-risk structural/process defects in medical devices.
Plain-English summary
Customed, Inc. is recalling 1,020 units of Premium Laparotomy Packs, Catalog number 900-1296. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because the products have compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and 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 140513344, 140613813, 140714389, and 140814943. Medical facilities should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Premium Laparotomy Pack, Catalog number 900-1296. 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
- 1,020
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 140513344 140613813 140714389 140814943
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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