Device product
Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.
Z-1227-2015
Product summary
- Event
- Event 70128
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,404,230
- Official record key
device-enforcement:Z-1227-2015
Official wording
Reason: Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.
Code information: All DiscPac products are affected within expiry up to October 2017
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.