Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall NeuRx DPS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall NeuRx DPS see related information
Date Initiated by Firm May 31, 2022
Create Date July 18, 2022
Recall Status1 Terminated 3 on April 11, 2024
Recall Number Z-1393-2022
Recall Event ID 90386
HDE Number H100006 
Product Classification diaphragmatic/phrenic nerve laparoscopically-implanted stimulator - Product Code OIR
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 Synapse Biomedical Inc
300 Artino St
Oberlin OH 44074-1263
For Additional Information Contact Sandy Brisbin
888-767-3770
Manufacturer 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).
FDA Determined
Cause 2		 Labeling design
Action On May 31, 2022, the firm began to contact all affected customer sites. Customers were informed that the way the temperature storage conditions are stated on the labeling of these devices could lead to improper storage that, under certain circumstances, could damage the devices. Synapse will visit customer facilities to place a label with proper storage conditions over the current storage conditions on the device label. Customers who would rather not have a site visit may destroy their devices and Synapse will replace them. The firm will also provide a revised Surgeon Instruction Manual that includes a description of the storage temperature symbol.
Quantity in Commerce 71
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.
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.
HDE Database HDEs with Product Code = OIR and Original Applicant = SYNAPSE BIOMEDICAL
-
-