CLASS II Device recall · Reported 25 Mar 2015 · FDA Enforcement Report
BD Posiflush Saline Flush Syringe inlcuded recalled
Bard Access Systems is recalling BD Posiflush Saline Flush Syringe inlcuded in the following device kits: Groshong Midline, distributed nationwide in the US. The recall was initiated on 8 Aug 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1275-2015
- FDA event ID
- 70430
- Recalling firm
- Bard Access Systems, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2014
- FDA classified
- 13 Mar 2015
- Reported
- 25 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 8 Aug 2014 | Recall initiated by company | |
| 13 Mar 2015 | Classified by FDA | +217 days |
| 25 Mar 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Where it was distributed
US Nationwide Distribution.
Questions about this recall
Is BD Posiflush Saline Flush Syringe inlcuded in the following device kits: Groshong Midline recalled?
Yes. Bard Access Systems recalled BD Posiflush Saline Flush Syringe inlcuded in the following device kits: Groshong Midline on 8 Aug 2014. The recall is Class II and its status is Terminated. Recall number Z-1275-2015.
Why was it recalled?
Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits.
Which lots are affected?
Lot Numbers: 13FB8860 Product codes: CK000069
Where was it sold?
US Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bard Access Systems
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | 5605150 Power-Trialysis Short-Term Straight Dialysis recalled | Bard Access Systems | Other | Nationwide |
| Device | CLASS II | 1174108 PowerPICC Catheter Single-Lumen recalled by Bard Access Systems | Bard Access Systems | Other | Nationwide |
| Device | CLASS II | 4380 Economy Soft Tissue Biopsy Tray recalled by Bard Access Systems | Bard Access Systems | Other | Nationwide |
| Device | CLASS II | CK000980A PowerMidline Catheter Dual-Lumen recalled | Bard Access Systems | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |