Philips 5-Lead Set recall
Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are…
Why was Philips 5-Lead Set recalled?
The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
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?
Lot codes: 03/18, 05/18 and 06/18
- Product
- Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are…
- Recalling firm
- Philips North America, LLC
- Quantity
- 280 boxes ( 5600 leadsets)
- Distribution
- Worldwide Distribution - US Nationwide State KY AZ CA UT OH NY SC CO FL IN TX ND KS GA Canada Germany
- Recall date
- September 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)