Reported Mar 14, 2018 · Terminated
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer…
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- BIO CAL(R) Temperature Controller
- Models
(a) 370(b) 370I
- Product UsageThe BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired
- Lot codes and dates
- (a) Model 370
- Serial Numbersn/a 0321 n/a 0542 n/a 0763 n/a AK0984 n/a AK1205 n/a AK1426 n/a AK1647 (b) Model 370I
1,540 of 1,540 codes
0101021103220432054306530764AK0874AK0985AK1095AK1206AK1316AK1427AK15370102021203230433054406540765AK0875AK0986AK1096AK1207AK1317AK1428AK15380103021303240434054506550766AK0876AK0987AK1097AK1208AK1318AK1429AK15390104021403250435054606560767AK0877AK0988AK1098AK1209AK1319AK1430AK15400105021503260436
- Serial Numbers
541 of 541 codes
I0101I0140I0179I0218I0257I0296I0335I0374I0413I0452I0491I0530I0569I0608I0102I0141I0180I0219I0258I0297I0336I0375I0414I0453I0492I0531I0570I0609I0103I0142I0181I0220I0259I0298I0337I0376I0415I0454I0493I0532I0571I0610I0104I0143I0182I0221I0260I0299I0338I0377I0416I0455I0494I0533I0572I0611I0105I0144I0183I0222
- Amount recalled
- 1980 units
Why it was recalled
Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices.
This product could cause temporary or reversible health problems — stop using it.
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