FDA Device recall Z-1275-2015
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syrin…
- FDA Device
- Class II
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class II recall of BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syrin… by Bard Access Systems, citing 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 so….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1275-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-08 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bard Access Systems |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | Lot Numbers: 13FB8860 Product codes: CK000069 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1275-2015%22
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