(1) BOX 01kbar006116v Proc Bypass 01kbar0061(item Code recall
(1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0)…
Why was (1) BOX 01kbar006116v Proc Bypass 01kbar0061(item Code 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 :0214710711 (2) Lot Number: 0214043771,0214232317,0214375093 (3) Lot Number: 0215113531,0215132607
- Product
- (1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0)…
- 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)