NeuRx Diaphragm Pacing System recall: Labeling Error
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System…
Why was NeuRx Diaphragm Pacing System recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Synapse Biomedical Inc
- Quantity
- 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.
- Recall date
- July 27, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)