Customed Recalls Pediatric Lap Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
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 is classified as FDA Class II. The hazard involves inadequate sterilization validation for medical devices, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 48 Pediatric Lap Packs (Code 9001383) that were distributed in Puerto Rico. The recall was initiated because the sterilization processes and package integrity for these products were not adequately validated or qualified before they were released for distribution as sterile.
The affected lots include 141015794 (exp. 10/30/15), 150116992 (exp. 2/28/16), 150217265 (exp. 2/28/16), 150318107 (exp. 3/31/16), and 150619131 (exp. 6/30/16). These packs are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
The source text does not specify specific actions for consumers or medical facilities beyond the recall notice itself. Medical facilities should verify their inventory against the listed lot numbers and expiration dates.
The recalled product
- Product
- PEDIATRIC LAP PACK 8/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 Packs
- Affected units
- 48
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 risk
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighMedline Micro-Kill Bleach Germicidal Wipes Recalled for Reduced Concentration
FDA (Devices) · 2026-08-19
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
- HighFlexible Hystero-Fiberscope Kits Recalled Due to Expired Sterile Seals
FDA (Devices) · 2026-07-29
- SevereFDA Recalls Rohto Dry-Aid Eye Drops Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29