Customed Recalls Angiodrape Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling Angiodrape Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
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 medical device where the risk of harm (infection from non-sterile equipment) is significant, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling Angiodrape Packs (Code 900366) distributed in Puerto Rico. The recall involves specific lots with expiration dates of 11/30/15 and 3/31/16. These products are used by medical staff for surgical procedures and patient care, including wound healing and suture removals.
The recall was initiated because the sterilization processes and package integrity for these products were not adequately validated or qualified. This means there is a risk that the products may not be sterile as intended.
Medical facilities and consumers in Puerto Rico who have these specific lots should stop using the products and contact Customed, Inc. for further instructions.
The recalled product
- Product
- ANGIODRAPE PACK DAMAS 6/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
- 6
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 · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighCustomed Arthroscopy Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- HighCustomed Laparotomy Packs Recalled for Sterilization Validation Defects
FDA (Devices) · 2016-04-20
- HighCustomed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20
- SevereCustomed Angiodrape Packs Recalled for Compromised Sterility and Contamination Risk
FDA (Devices) · 2014-12-10
- HighCustomed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
FDA (Devices) · 2016-04-20