Customed Femoral Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 320 units of Femoral Packs due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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. Per the rubric, Class II recalls without explicit reports of hospitalization or significant injury are typically scored as High (3), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 320 units of the Femoral Pack 5/CS. These medical supplies are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as issues with package integrity for products released for distribution as sterile.
The affected product is identified by code 900164. The specific lots involved include 141015751 (exp. 11/30/15), 141216294 (exp. 12/31/15), 150217276 (exp. 2/28/16), 150317630 (exp. 2/28/16), 150418311 (exp. 3/31/16), 150518655 (exp. 2/28/16), and 150519025 (exp. 3/31/16). The source text indicates that these products were distributed only in Puerto Rico.
Healthcare facilities and consumers in Puerto Rico should check their inventory for these specific lot numbers and stop using the affected products. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- FEMORAL PACK 5/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
- Affected units
- 320
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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