Device product
Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC
Z-2387-2026
Product summary
- Event
- Event 98793
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 90
- Official record key
device-enforcement:Z-2387-2026
Official wording
Reason: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Code information: REF(Material)/UDI-DI/Lot(Batch): CDC-32052-MPKC/10801902193275/33F24L0236
Distribution pattern: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
Derived failure modes
-
Unknown
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.