Customed Medical Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 160 Higado & Pancrea 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 text explicitly states that the compromised sterility '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 'Severe' (4) criteria for significant injury reports or high-risk structural/process defects in medical devices.
Plain-English summary
Customed, Inc. is recalling 160 units of the Higado & Pancrea Pack, Catalog number 900-1966. These medical packs are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because of 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 in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140513119, 140613951, and 140714510. Medical facilities should stop using these products and contact the recalling firm for instructions.
The recalled product
- Product
- Higado & Pancrea Pack, Catalog number 900-1966. 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
- Hazard
- Affected units
- 160
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 140513119 140613951 140714510
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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