Recall Z-2047-2015— Bard Access Systems
Class III · Terminated
Class III FDA medical device recall by Bard Access Systems, initiated 2015-05-27, terminated 2016-02-10. It names 2 FDA 510(k) clearances: K091324, K072230. Product: PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.. Reason: Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling..
- Recalling firm
- Bard Access Systems
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-05-27
- Terminated
- 2016-02-10
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
2 on FDA's record- K091324 — SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
- K072230 — POWERPICC SOLO
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
PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
Reason for recall
Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.
Data sourced from openFDA. This site is unofficial and independent of the FDA.