CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report
Celerity ECG Cable Accessory Pack, Sterile recalled
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Celerity ECG Cable Accessory Pack, Sterile, distributed in 19 states. The recall was initiated on 7 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1137-2017
- FDA event ID
- 75226
- Recalling firm
- Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Sep 2016
- FDA classified
- 3 Feb 2017
- Reported
- 15 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Sep 2016 | Recall initiated by company | |
| 3 Feb 2017 | Classified by FDA | +149 days |
| 15 Feb 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
Where it was distributed
AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI
ArizonaCaliforniaFloridaGeorgiaIllinoisIndianaKansasMarylandMissouriMontanaNorth CarolinaNew JerseyNevadaOhioOregonPennsylvaniaTennesseeTexasWisconsin
Questions about this recall
Is Celerity ECG Cable Accessory Pack, Sterile recalled?
Yes. Angiodynamics Inc. (Navilyst Medical Inc.) recalled Celerity ECG Cable Accessory Pack, Sterile on 7 Sep 2016. The recall is Class II and its status is Terminated. Recall number Z-1137-2017.
Why was it recalled?
The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal.
Which lots are affected?
AngioDynamics UPN H787471431 Batch/Lot Numbers: 5015180, MBVR240D, MBVT150R, MBVT210D, MBVT220D, MBVT240D, MBVT250D, MBVT680D, MBVT700D, MBVX090D; medCOMP UPN MRLCA000, Batch/Lot Number MBVT240.
Where was it sold?
AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Angiodynamics Inc. (Navilyst Medical Inc.)
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Xcela PICC with Pasv Valve Technology/Kit 5 F recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | NY |
| Device | CLASS II | Smart Port CT-Implantable Port recalled by Angiodynamics Inc. (Navilyst | Angiodynamics Inc. (Navilyst Medical Inc.) | Sterility | Nationwide |
| Device | CLASS II | AngioDynamics Safe Sheath Ultralite recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Sterility | Nationwide |
| Device | CLASS II | Starburst Talon Semi-Flex Electrosurgical Device recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Labeling Errors | 5 states |
| Device | CLASS II | Bioflo 8f Single Plastic Non-filled recalled | Angiodynamics Inc. (Navilyst Medical Inc.) | Foreign Material | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |