Customed Laparoscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 32 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is related to process validation rather than a confirmed high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
Customed, Inc. is recalling 32 units of Laparoscopy Packs (Code: 9003178, Lot: 140915334, exp. 10/31/15). These sterile medical device packs are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected products were distributed only in Puerto Rico.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take, such as returning the product or seeking medical attention.
The recalled product
- Product
- LAPAROSCOPY PACK 2/CS 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 Packs
- Affected units
- 32
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:9003178 Lot: 140915334 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 →Related recalls
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