Recall Z-0769-2019— WEST PHARMA. SERVICES IL, LTD
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 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only. Reason: Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC..
- 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 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
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
Reason for recall
Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC.
Data sourced from openFDA. This site is unofficial and independent of the FDA.