FDA Devices recall · Reported August 27, 2014
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.
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 prod…
Icu Medical, Inc. recalled CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packag… - a moderate-severity action.
CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packag… was recalled by Icu Medical, Inc. in August 27, 2014. Reason: ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may e…. Check the official notice for the remedy. Verify recall #Z-2293-2014 with the FDA Devices before acting.
The recall
Icu Medical, Inc. issued this moderate-severity FDA Devices recall-ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may e….
- Moderate
- severity level
- 300 units
- affected scope
- Class II
- classification
- August 27, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2293-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2293-2014 |
| Date reported | August 27, 2014 |
| Date initiated | August 5, 2014 |
| Recalling firm | Icu Medical, Inc. |
| Firm location | San Clemente, CA |
| Affected scope | 300 units |
| Distribution | Nationwide Distribution - USA including AL and MD. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2293-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026