Device product
Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG KIT DT13191A PORT A CATH CDS982047S VEIN ABLATION PACK DYNJ62889C
Z-2419-2026
Product summary
- Event
- Event 98951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,654 kits total
- Official record key
device-enforcement:Z-2419-2026
Official wording
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Code information: DYNDC3525 UDI-DI 10198459576294 Lot 25KBM985 DT13191A UDI-DI 10653160998914 Lot 26AMA168 CDS982047S UDI-DI 10198459385735 Lot 26AMB202 DYNJ62889C UDI-DI 10198459416453 Lot 26AMA584
Distribution pattern: US Nationwide distribution. OUS distribution pending.
Derived failure modes
-
Unknown
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.