Recall Z-0771-2017— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2016-11-22, terminated 2017-11-24. It names one FDA 510(k) clearance: K010420. Product: RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization. Reason: Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-22
- Terminated
- 2017-11-24
- Firm location
- Research Triangle Park, NC, 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
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
Reason for recall
Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.