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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 28, 2004
Date Posted September 21, 2004
Recall Status1 Terminated 3 on November 22, 2004
Recall Number Z-1483-04
Recall Event ID 29941
510(K)Number K032338  
Product Classification Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) - Product Code DRT
Product Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Code Information Serial Numbers:    MC01475-D3; MC02325-K3; MC01476-D3; MC02120-I3; MC02017-I3; MC02004-I3; MC02011-I3; MC02018-I3; MC02047-I3; MC02039-I3; MC02196-I3; MC02279-K3; MC02295-K3; MC02298-K3; MC01478-D3; MC01491-D3; MC01496-D3; MC01865-G3; MC01455-D3; MC02281-K3; MC02237-I3; MC05179-C4; MC05180-C4; MC05191-C4; MC05194-C4; MC05206-C4; MC05218-C4; MC05223-C4; MC01497-D3; MC01452-D3; MC01473-D3; MC01490-D3; MC01493-D3; MC01861-G3; MC02354-K3; MC02293-K3; MC02303-K3; MC02316-K3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02292-K3; MC01487-D3; MC02285-K3; MC02309-K3; MC02313-K3; MC05082-C4; MC05107-C4; MC02306-K3; MC01862-G3; MC01918-H3; MC01479-D3; MC05183-C4; MC05189-C4; MC01474-D3; MC01477-D3; MC01450-D3; MC05072-C4; MC05075-C4; MC05083-C4; MC05089-C4; MC05090-C4; MC05105-C4; MC05178-C4; MC05195-C4; MC05209-C4; MC05210-C4; MC05212-C4; MC05213-C4; MC05214-C4; MC05215-C4; MC05217-C4; MC05224-C4; MC01448-D3; MC01449-D3; MC01464-D3; MC01481-D3; MC01495-D3; MC01859-G3; MC01867-G3; MC01890-H3; MC02348-K3; MC02359-K3; MC02363-K3; MC01453-D3; MC01860-G3; MC02199-I3; MC01460-D3; MC01806-G3; MC01954-H3; MC02135-I3; MC02136-I3; MC02146-I3; MC02168-I3; MC02171-I3; MC02278-K3; MC02280-K3; MC05172-C4; MC05173-C4; MC05174-C4; MC05181-C4; MC05184-C4; MC05188-C4; MC05190-C4; MC05201-C4; MC05203-C4; MC05208-C4; MC05219-C4; MC05222-C4; MC05225-C4; MC05227-C4; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3; MC05182-C4; MC05185-C4; MC05192-C4; MC05199-C4; MC01869-G3; MC02326-K3; MC02344-K3; MC02357-K3; MC02365-K3; MC01866-G3; MC01868-G3; MC01929-H3; MC01949-H3; MC02187-I3; MC02277-K3; MC01482-D3; MC01488-D3; MC02177-I3; MC02290-K3; MC02317-K3.
Recalling Firm/
Manufacturer		 Datascope Corp
800 MacArthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Susan E. Mandy
201-995-8025
Manufacturer Reason
for Recall		 The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.
FDA Determined
Cause 2		 Other
Action On July 28, 2004, the firm sent out a Urgent Product Field Correction via FedEx to their customers. Enclosed with this letter was the replacement feet, an Instruction form and a field correction completion form.
Quantity in Commerce 146
Distribution Product was shipped to hospitals and medical clinics nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRT and Original Applicant = DATASCOPE CORP.
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