FDA Device recall Z-1605-2013
Brand Name: SV Elastomeric Infusion Device
- FDA Device
- Class II
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class II recall of Brand Name: SV Elastomeric Infusion Device by Baxter Healthcare, citing baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1605-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-07 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
Reason
Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
Identifiers
| code_info | Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP Lot Codes: 08J078 08K002 08K005 08K007 08K054 08K066 08M001…Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP Lot Codes: 08J078 08K002 08K005 08K007 08K054 08K066 08M001 08M025 08M028 08M039 08N003 08N005 08N032 09A004 09A040 09A042 09A064 98025 98027 98028 98070 09(018 09C023 09(024 09C045 09C047 09(075 90029 90031 90033 90065 90069 90086 09E026 09E027 09E031 09F023 09F024 09F025 09F040 09F041 09F042 09G013 09G061 09G062 09H004 09H008 09H035 09H036 09H070 09H082 09J006 09J007 09J074 09J075 09K017 09K018 09K021 09K022 09K086 09K087 09M002 09M005 09M037 09M038 09M039 09M078 09N027 09N028 09N029 09N034 10A019 10A020 10A021 10A044 108010 108029 10C002 10C003 10C006 10C078 10C079 10C099 10C103 10C111 100026 100027 100028 100058 100062 100063 10E003 10E008 10E009 10E067 10G005 10G006 10G007 10G008 10G078 10G079 10H014 10H019 10H020 10H022 10H054 10H056 10H057 10H060 10H069 10H071 10H105 10H107 10J022 10J023 10J026 10J028 10J029 10J |
|---|
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-1605-2013%22
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