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.
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HDE Database | HDEs with Product Code = OIR
|