Recall Z-0767-2019— WEST PHARMA. SERVICES IL, LTD

Name: FDA recall Z-0767-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-26

Class I · Terminated

Class I FDA medical device recall by WEST PHARMA. SERVICES IL, LTD, initiated 2018-12-26, terminated 2022-07-20. It names one FDA 510(k) clearance: K170095. Product: Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only. Reason: Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solution in the IV bag. This could lead to concentrated drug pooling in the device and bolus injections..

Recalling firm: WEST PHARMA. SERVICES IL, LTD
Classification: Class I
Status: Terminated
Initiated: 2018-12-26
Terminated: 2022-07-20
Firm location: Ra'Anana, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K170095 — Vial2Bag Direct ConnectMedimop Medical Project , Ltd.·cleared 2017-03-08

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

Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only

Reason for recall

Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solution in the IV bag. This could lead to concentrated drug pooling in the device and bolus injections.

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