Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 Intra-Aortic Balloon Pumps (IABPs), Part Number 0012-00-1589-03

FDA Recall Z-0266-2020 · Posted None

Recalling FirmDatascope Corp.
Recall StatusTerminated
Product CodeMHX
Date Initiated2019-10-03
Date Terminated2021-01-08
Product Quantity7

Reason for Recall

One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.

Firm Action

On October 3, 2019, the firm notified customers of the recall via an Urgent Medical Device Recall letter. The letter alerted customers that the incorrect cable may have been supplied. Customers were asked to take the following actions: -Please examine your inventory immediately, remove and quarantine any affected product. - If you have unused affected product, please contact Getinge Customer Service at 1-888-627-8383 (press option 2, then option 1) between the hours of 8 AM and 6 PM Eastern Standard Time to request a material authorization number (RMA) and shipping instructions. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider. Replacement product or a credit will be issued for your return. -Please enter the quantity and RMA number provided by Customer Service in the spaces provided on the URGENT MEDICAL DEVICE RECALL REMOVAL Response Form on Page 4 of the letter, if you are returning products to Datascope/Getinge. -Please complete and sign the attached URGENT MEDICAL DEVICE RECALL REMOVAL RESPONSE FORM (page 4) to acknowledge that you have received the notification. Return the completed form to Datascope/Getinge by emailing a scanned copy to [email protected] or by faxing the form to 1-973-807-9290. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Customer Service at 1-888-627-8383 (press option 2, then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed to CA, GA, and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑