Customed Femoral Angiography Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 236 units of Femoral Angiography Packs 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 medical device with compromised sterility that may result in patient infection, which aligns with the rubric criterion for 'significant injury' reports or high-risk contamination in medical devices.
Plain-English summary
Customed, Inc. is recalling 236 units of the Femoral Angiography Pack, Catalog number 900-796. This product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall involves specific lot numbers: 140513145, 140513340, 140613848, 140814683, and 140915202.
The recall is being issued because of significant 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. Medical facilities and consumers who have these specific products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Femoral Angiography Pack, Catalog number 900-796. 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
- 236
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 140513145 140513340 140613848 140814683 140915202
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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