Customed Angiography Packs Recalled for Sterilization Process Validation Deficiencies
Customed, Inc. is recalling 1,128 angiography packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
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 is classified as FDA Class II. The hazard involves potential sterility failure in medical devices used for surgical procedures, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 1,128 units of Angiography Packs (Code 900210) distributed exclusively in Puerto Rico. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile.
The affected lots include 140915501, 150116701 through 150116706, 150217378 through 150217382, 150317720, 150317721, 150318115 through 150318118, and 150418270 through 150418273. These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
The source text does not specify specific actions for consumers or medical facilities beyond the recall notice itself. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 1,128
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 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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