Customed Neuro-Spine Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 81 Neuro-Spine Surgical 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 involves a sterile medical device with inadequate sterilization validation, creating a risk of infection (risk-of-harm product) without reported illness, which aligns with the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 81 units of the Neuro-Spine Surgical Pack (Catalog Number 9001300). These sterile medical device packs are used by medical staff to perform surgical procedures and patient care procedures, such as 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 the products released for distribution as sterile. The affected lots are SL15202, SL15209, SL15215, and SL15265, with distribution dates ranging from June 30, 2016, to September 30, 2016.
The products were distributed only in Puerto Rico. No specific illnesses or injuries have been reported in the source text. Healthcare facilities and consumers should stop using these specific lots and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK 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
- 81
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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 100 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 · infection
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19