Class III Recall

NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx

Summary

The FDA issued a Class III for NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # by Synapse Biomedical Inc. Reason: Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbo.

Details

Source

Device Recall

External ID

Z-1393-2022

Action Date

2022-07-27

Status

Terminated

Product Description

NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

Lot/Code Info: UDI-DI: 00852184003007 00852184003045 00852184003038 00852184003267 00852184003090 00852184003106 00852184003113 00852184003120 00852184003137 00852184003144 00852184003151 00852184003168 00852184003175 00852184003182 00852184003281 00852184003052 Lots/Serial Numbers: 20-0035-113021-3-3 20-0035-120221-2-1 20-0035-121621-5-2 20-0035-121621-5-3 20-0035-010722-5-4 20-0035-010722-5-5 20-0035-030722-2-2 20-0035-031122-5-1 20-0035-031122-5-2 20-0035-031122-5-5 20-0035-033122-5-1 20-0035-033122-5-2 20-0035-033122-5-3 20-0035-040622-4-1 20-0035-040622-4-2 20-0035-040622-4-3 20-0035-040622-4-2 20-0035-042122-1-1 20-0028-060221-5 20-0028-062421-5 20-0028-062521-5 20-0028-072821-5 20-0028-031022-5 20-0040-012221-10 20-0040-012221-10 20-0040-021921-9 20-0040-012221-10 20-0040-012221-10 20-0040-021921-9 20-0040-021921-9 20-0040-021921-9 20-0040-021921-9 20-0040-012621-10 20-0040-012621-10 20-0040-012621-10 20-0040-012621-10 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-071321-6 20-0040-071321-6 20-0040-092021-10 20-0040-092021-10 20-0040-071521-2 20-0040-092021-10 20-0040-092021-10 20-0040-092021-10 20-0040-100721-10 20-0040-100721-10 20-0040-100721-10 20-0040-100721-10 20-040-100721-10 20-0040-100721-10 20-0040-100721-10 20-0040-122121-10 20-0040-122121-10 20-0040-122121-10 20-0040-122121-10 20-0040-010622-10 20-0040-121621-1 20-0040-020822-10 20-0040-010622-10 20-0040-040122-2

Quantity Affected: 71

Reason for Recall

Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

Distribution

Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX WV. Foreign distribution pending.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-05-31

Company

Synapse Biomedical Inc

Oberlin, OH

Context & Analysis

This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.

This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Synapse Biomedical Inc has 3 FDA actions in our database, including 2 recalls and 1 clearance.

Frequently Asked Questions

What is a Class III recall?

A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Synapse Biomedical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Synapse Biomedical Inc have FDA actions?

Synapse Biomedical Inc has 3 FDA actions in our database, including 2 recalls and 1 device clearance.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1393-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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