Customed Plastic Surgery Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 105 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Customed, Inc. is recalling 105 units of the Plastic Surgery Pack, Catalog # 900-920. These packs are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall involves lot numbers 140513470 and 140714316.
The recall was initiated 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 risk may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities that received these products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Plastic Surgery Pack, Catalog # 900-920 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
- 105
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 140513470 140714316
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.
See all 179 products in this recall →Related recalls
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