Datascope Corp Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Brand
Datascope Corp
Lot Codes / Batch Numbers
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.
Products Sold
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.
Datascope Corp is recalling Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm). due to The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026