Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
Recall
- Recall Number
- Z-0769-2019
- Event Number
- 81877
- Firm
- WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel
- FEI Number
- 3000223297
- Product Code
- LHI
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 26, 2018
- Posted
- January 28, 2019
- Terminated
- July 20, 2022
Description
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
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.
On December 26, 2018, West Pharmaceutical Services, Inc. issued URGENT MEDICAL DEVICE CORRECTION and ACKNOWLEDGEMENT FORMS to their customers asking customers to avoid use of the drug oxytocin with the device. Actions to be taken by the Distributor: 1. Complete the required Acknowledgement and Receipt Form below and return (via email) to [email protected] when complete (See attached form). 2. Prior to filling order / releasing shipments of any Vial2Bag DC 13mm products (which have been placed on hold per our request) to hospital customers, affix a copy of this Voluntary Field Corrective Action Notice to each carton of Vial2Bag DC 13mm products in your possession. 3. Notify and provide the letter to all accounts/customers where the Affected Product was distributed. 4. Because the assessment is ongoing, please be prepared for updates to the notification. Actions to be taken by the Customer/User: 1. As a temporary measure you should avoid use of the drug oxytocin with the Vial2Bag DC 13mm until further notice until a full assessment has been completed. 2. Affix the notice to each carton of Vial2Bag DC 13mm products in your possession. 3. In addition, provide the notice to personnel with responsibilities related to product selection and administration, and according to your internal procedures for notification of field corrective actions. 4. Please complete the Recall Acknowledgement and Receipt Form and return to Karen Crimi by email at [email protected] when complete responses are available. On January 24, 2019, West Pharmaceutical Services, Inc. initiated a product removal and broadened their action by distributing AMENDED URGENT MEDICAL DEVICE RECALL notices to their customers to include removal of three (3) devices from the field. On February 1, 2019, West Pharmaceutical Services, Inc. expanded their recall to include an additional sixteen (16) lots and issued notices titled - 2nd AMENDED URGENT MEDICAL DEVICE RECALL not
US Distributor in MO
30 million units