PMRA / MBTS DocumentPMRA / MBTS blood-bag recall, 19 November 2022
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Product recall: CPDA-1 single blood bags manufactured by Linwell Medical Company Limited is published by Pharmacy and Medicines Regulatory Authority / Malawi Blood Transfusion Service. This document is identified by its title; no separate official document code is recorded.
- Instrument
- Document
- Full name
- PMRA / MBTS blood-bag recall, 19 November 2022
- Category
- Vigilance
- Source publication
- English
- Readable HTML
- 1 language version
- Published
- 2022-11-19
- Effective
- —
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Product recall: CPDA-1 single blood bags manufactured by Linwell Medical Company Limited
Complete one-page signed joint PMRA/MBTS recall notice dated 19 November 2022, retained with its original page image. It orders the immediate recall and return to the source of Linwell CPDA-1 sterile 450 ml single blood bags with 16G needle, lot 210403, manufactured April 2021 and expiring March 2024, following failure of MBTS quality-control validation specifications. The manufacturer was informed through the local supplier; both authority signatories and contact details are retained. This is a product- and lot-specific enforcement notice, not a general device variation procedure or an approval timeline. The 2024 upload directory is not its issue date, and the product expiry is not a stated legal expiry of the recall. Its later closure/current operational status has not been verified, so it is excluded from default current discovery and remains directly readable.
This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.