Aural Ventilation Tubes
Aural Ventilation Tubes Recall Exmoor Plastics Ltd is recalling Aural Ventilation Tubes distributed to hospitals, pharmacies, and laboratories in New Zealand. The tubes must be destroyed. This is a Class I recall, the most serious classification.
- Recalling firm
- Bio Serve NZ Limited
- Product
- Aural Ventilation Tubes. [Device]. Model: Shah Ventilation Tubes - none/PTFE/White/1.14/3.61/2.59/1.42/2.41. Affected: Lot number - 11998
- Reason
- The manufacturer changed its steam sterilisation supplier for PTFE grommets and identified an issue during onboarding where a small number of units from certain lots showed visible sterile-barrier breaches during post-sterilisation inspection. A subsequent review of products from a specific sterilisation cycle found that sterility could not be confirmed with complete certainty, although the likelihood of a breach was assessed as less than 0.5%. As a precaution, a recall has been initiated for all affected lots.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-04-24
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/8bfaad57-9721-4bfe-a14c-2391ee9b307d