(1)kit4184 Apen Lobectomy KIT X0 recall
(1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11…
Why was (1)kit4184 Apen Lobectomy KIT X0 recalled?
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
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?
(1)Lot Number: 0214962218 (2) Lot Numbers: 02148663335, 0214993030, 0215178525
- Product
- (1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11…
- Recalling firm
- COVIDIEN MEDTRONIC
- Quantity
- 171,271 units in total
- Distribution
- Worldwide and US Nationwide
- Recall date
- May 23, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)