Customed Laparoscopy Cholecystectomy Surgical Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 192 units of Laparoscopy Cholecystectomy Surgical 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 text explicitly states that the compromised sterility 'may result in patient infection,' which constitutes a risk of significant injury. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios.
Plain-English summary
Customed, Inc. is recalling 192 units of the Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. The affected lots are 140513373, 140613770, 140614115, 140714333, 140814678, and 140915190. These products were distributed in the United States to Florida, New York, and Puerto Rico.
The recall is due to significant compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. This may result in patient infection.
Medical staff who used these packs for patient care procedures should stop using the affected units and contact Customed, Inc. for further instructions.
The recalled product
- Product
- Laparoscopy Cholecystectomy Surgical Pack, Catalog number 900-576A. 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
- 192
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 140513373 140613770 140614115 140714333 140814678 140915190
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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