Customed Open Heart Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 47 Open Heart Surgical Packs distributed in Puerto Rico 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 involves a risk-of-harm product (sterile surgical pack) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 47 units of the Open Heart Surgical Pack (Catalog Number 9002618). These sterile medical device packs 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 the sterilization processes and package integrity for the products released for distribution as sterile. The affected lots were distributed only in Puerto Rico.
The specific lot numbers and dates associated with this recall are SL15177 (30-JUN-16), SL15181 (30-JUN-16), SL15212 (31-JUL-16), SL15215 (31-JUL-16), SL15219 (31-JUL-16), and SL15271 (30-SEP-16). Healthcare facilities and consumers should stop using these products and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Catalog Number: 9002618 OPEN HEART 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
- 47
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 · 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 Indicator Recall Due to Spore Population Concerns
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
Similar recalls
- HighCustomed Open Heart Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Plastic Surgery Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09
- HighCustomed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2015-09-09