Recall Z-0099-2015— Intra Pump Infusion Systems
Class II · Terminated
Class II FDA medical device recall by Intra Pump Infusion Systems, initiated 2013-10-18, terminated 2016-02-01. It names 5 FDA 510(k) clearances: K052218, K052217, K052219 and 2 more. Product: CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle". Reason: Product has the potential to have a clear debris on the tip of the needle..
- Recalling firm
- Intra Pump Infusion Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-18
- Terminated
- 2016-02-01
- Firm location
- Grapevine, TX, United States
510(k) clearances named in this recall
5 on FDA's record- K052218 — CRONO FIVE AND CRONO PCA 50
- K052217 — CRONO SUPER PID
- K052219 — CRONO GO.
- K042085 — CRONO F
- K041414 — CRONO AND CRONO, MODEL 30
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Reason for recall
Product has the potential to have a clear debris on the tip of the needle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.