Recall Z-2281-2019— Canadian Hospital Specialties

Name: FDA recall Z-2281-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-16

Class II · Terminated

Class II FDA medical device recall by Canadian Hospital Specialties, initiated 2019-07-16, terminated 2025-05-28. It names one FDA 510(k) clearance: K100700. Product: MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R. Reason: The firm received a complaint that the connector detached from the feeding tube..

Recalling firm: Canadian Hospital Specialties
Classification: Class II
Status: Terminated
Initiated: 2019-07-16
Terminated: 2025-05-28
Firm location: Oakville, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESBenlan, Inc.·cleared 2010-12-13

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

MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R

Reason for recall

The firm received a complaint that the connector detached from the feeding tube.

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