Z-1034-2016 Class II Terminated
FDA device recall Z-1034-2016 was initiated by Covidien LLC on Jan 21, 2016 and is designated Class II. Reason for recall: 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs The recall status is terminated (terminated Jun 1, 2017). Affected quantity: 1,330 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 9, 2016
- Initiation Date
- Jan 21, 2016
- Termination Date
- Jun 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,330 units
Product Description
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
Reason for Recall
8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
Distribution Pattern
Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
Code Information
Lot Code: 521808064X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1034-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026