Customed NEURO PACK Surgical Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 64 NEURO PACK surgical kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
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. The hazard involves potential exposure to non-sterile medical devices, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 64 units of NEURO PACK surgical kits. These products are used by medical staff to perform surgical procedures and patient care tasks, including wound healing, suture removals, and wound irrigation. The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile.
The affected lots were distributed only in Puerto Rico. The specific lot numbers and expiration dates are 141015762 (exp. 11/30/15), 141216323 (exp. 12/31/15), 150116792 (exp. 3/31/16), 150518691 (exp. 5/31/16), and 150317817 (exp. 5/31/16). The product code is 9002256.
Medical facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- NEURO PACK 2/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 Kits
- Affected units
- 64
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.
See all 170 products in this recall →Related recalls
Same manufacturer · Customed, Inc
See all →- HighCustomed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Femoral Surgical Pack Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
Same hazard · sterilization failure
See all →- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighCustomed Neurosurgery Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Neuro-Spine Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Cesarean Section Surgical Packs Recalled for Sterilization Defects
FDA (Devices) · 2016-04-20
- HighCustomed Surgical Packs Recalled for Sterilization Validation Deficiencies
FDA (Devices) · 2016-04-20
- SevereCustomed Plastic Surgery Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Basic Surgical Packs Recalled for Sterilization Validation Defects
FDA (Devices) · 2016-04-20