Tube Set for TEM - Product Usage: Transanal Endoscopic recall
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed…
Why was Tube Set for TEM - Product Usage: Transanal Endoscopic recalled?
Tube material of a smaller diameter was used.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number 32324159, Model # 4170.801
- Product
- Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed…
- Recalling firm
- Richard Wolf GmbH
- Quantity
- 338 sets
- Distribution
- International distribution in the countries of Austria (AT), Canada (CA), Germany (DE), Denmark (DK), Spain (ES), France (FR), United Kingdom (GB), Hong Kong (HK), Iceland (IS), Lithuania (LT), Norway (NO), New Zealand (NZ), Sweden (SE), and Netherlands (NL).
- Recall date
- August 5, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)