Getinge Assured Batch Monitoring Pcd
- Recalling firm
- Getinge Australia Pty Ltd (NZ)
- Product
- Getinge Assured Batch Monitoring PCD. [Device]. Model: Model number - PL589/ 6005500575. Affected: 54043A
- Reason
- This problem was initiated by a customer product complaint regarding a missing O-ring. There have been no reported testing failures or adverse events, and the defect is unlikely to cause harm to the user. The root cause was identified as a combination of a supplier production process failure and an internal quality inspection error., Failure of the device, due to the missing O-ring, may state sterilisation cycle was not completed and may require re-sterilisation, which may disrupt workflow. This could result in delay of goods and, as such, delay of procedure; should this occur, it is...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-17
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/b4690f8e-afb2-427a-9564-a9ac76889674