CAP Change Kit w/MicroClave Clear — Class II medical device recall Z-2293-2014
Terminated recall by ICU Medical, Inc., reported 2014-08-27, distributed nationwide. ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may ex
| Recall number | Z-2293-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2014-08-05 |
| Classified | 2014-08-20 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-02-26 |
| Distributed | Nationwide (US) |
| Quantity | 300 units |
| Reason classes | sterility |
| Lot numbers | 2704633, 2705206 |
| Model numbers | B78109BD |
Product
CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Reason for recall
ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2293-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.