Recall Z-1034-2016— Covidien LLC

Name: FDA recall Z-1034-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-21

Class II · Terminated

Class II FDA medical device recall by Covidien LLC, initiated 2016-01-21, terminated 2017-06-01. It names one FDA 510(k) clearance: K820442. Product: 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: 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.

Recalling firm: Covidien LLC
Classification: Class II
Status: Terminated
Initiated: 2016-01-21
Terminated: 2017-06-01
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K820442 — ARGYLE INDWELL FEEDING TUBESherwood Medical Co.·cleared 1982-03-10

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.