Medtronic Perfusion Tubing Packs recall
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3…
Why was Medtronic Perfusion Tubing Packs recalled?
Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.
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?
209050007 209087876 209107465 209135076 209162502 209195930 209241496 209241613 209270018 209270092 209297994 209298091 209298094 209310403 209326025 209373545 209388464 209396017 209401269 209401312 209415313 209431890 209464644 209512240 209556873 209621268 209644548 209653827
- Product
- MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3…
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- Total 1594 (1306 US, 288 OUS)
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia.
- Recall date
- September 16, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)