Customed Laparoscopy Packs Recalled for Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 240 Laparoscopy Packs (Catalog 900-474) 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 recall involves a Class I medical device with significant compromised sterility and manufacturing deficiencies that may result in patient infection, meeting the criteria for a Severe rating due to the risk of serious injury.
Plain-English summary
Customed, Inc. is recalling 240 units of Laparoscopy Packs, Catalog number 900-474. These medical devices are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lots are 140513480, 140613838, 140814548, and 140814955.
The recall is being issued because of significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions. These factors increase the risk of contamination and may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Healthcare facilities and consumers who have these specific products should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Laparoscopy Pack, Catalog number 900-474. 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
- 240
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 140513480 140613838 140814548 140814955
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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