Customed Angiodrape Packs Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 1,152 Angiodrape 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 and contamination risk 'may result in patient infection.' Under the severity rubric, a risk of significant injury or harm (infection) in a medical device context aligns with a score of 4 (Severe), as it represents a significant health risk even if specific injury reports are not detailed in the provided text.
Plain-English summary
Customed, Inc. is recalling 1,152 units of the Angiodrape Pack, Catalog number 900-002. This medical device is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot numbers are 140513048, 140613547, and 140714116.
The recall was initiated 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. These conditions may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Healthcare facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 1,152
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 140513048 140613547 140714116
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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