Medline Industries Recalls Pediatric Catheter Securement Dressing Kits Over Sterility Concerns
Medline Industries, LP has issued a voluntary recall for 450 pediatric catheter securement dressing kits due to potentially compromised seals on included swabsticks.
What Happened
Medline Industries, LP has initiated a voluntary recall of specific medical convenience kits. The recall was prompted after it was determined that the BD ChloraPrep Triple Swabsticks included within these kits may exhibit open seals on their packaging. This defect was identified by BD and could compromise the sterility of the applicators.
Which Products Are Affected
The recall affects the following medical device kits:
- Product Name: Medline medical convenience kits packaged as PEDIATRIC CATH SECUREMENT DRSG
- Kit SKU: DYNDC3108
- Lot Number: 25EBD612
- UDI/DI: 10193489918007
- Quantity: 450 kits
- Recall Number: Z-1328-2026
These products were distributed nationwide across the United States.
What You Should Do
Healthcare providers and facilities should immediately check their inventory for the affected lot number (25EBD612). Medline Industries, LP has notified customers through various channels, including email, fax, letter, and telephone. If you possess the affected kits, you should follow the instructions provided by the manufacturer regarding the return or disposal of the product. For further inquiries, contact Medline Industries, LP at their Northfield, IL headquarters.
Why This Matters
Open seals on sterile medical components like swabsticks pose a risk of contamination. Using non-sterile equipment in pediatric catheter procedures could lead to serious infections or other adverse health complications for patients.
Source
This information is based on an official report from the FDA.
Source: FDA Official Notice