Recall Z-1303-2013— Covidien LLC
Class III · Terminated
Class III FDA medical device recall by Covidien LLC, initiated 2013-04-12, terminated 2015-06-02. It names one FDA 510(k) clearance: K842898. Product: Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.. Reason: On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits..
- Recalling firm
- Covidien LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-04-12
- Terminated
- 2015-06-02
- Firm location
- Mansfield, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.
Reason for recall
On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits.
Data sourced from openFDA. This site is unofficial and independent of the FDA.