Device product
Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory
Z-0195-2023
Product summary
- Event
- Event 90964
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1378 units
- Official record key
device-enforcement:Z-0195-2023
Official wording
Reason: Sterile extension sets were distributed without an expiration date
Code information: ALL LOT CODES
Distribution pattern: US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
Derived failure modes
-
Unknown
Sterile extension sets were distributed without an expiration date