Integra Drainage Accessory Kits recall
Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
Why was Integra Drainage Accessory Kits recalled?
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
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?
Catalog Number 910122, Lot #0195615 with expiry 04/2019
- Product
- Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch. Five (5) sealed Tyvek pouches are packaged in a cardboard box. Used for Intraoperative drainage of CSF
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 1
- Distribution
- Nationwide Distribution to KS only
- Recall date
- October 12, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)