5mm Endopath Xcel with Optiview Technology recall
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Why was 5mm Endopath Xcel with Optiview Technology recalled?
Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. In addition, insufficient lubrication could result in a remote chance of introducing a minute particle if repeated insertions of the obturator or laparoscopic device damage the seal.
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?
Lots P4T636 P4T63G P4T689 P4T708 P4T86Z P4T882 P4T89N P4T97L P4T994 P4TA0T P4TA17 P4TA55 P4TA70 P4TA7R P4TC53 P4TC7X P4TC87 P4TC8U P4TC93 P4TD1Y R4003L R40048 R4005Z R4010L R4012F R40142 R4020P R4021H R4027N R4042X R4045N R4046X R4054H
- Product
- 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 95233
- Distribution
- Nationwide domestic distribution, including PR. International distribution to Saudi Arabia, United Arab Emirates, Belgium, Singapore, Taiwan, South Korea, Canada, Chile, Mexico, Japan, and Argentina.
- Recall date
- May 23, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)