🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: May 31, 2022 Synapse Biomedical Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Synapse Biomedical Inc
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: AL, CA, CO, FL, GA, IL, MA, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SC, TX, WV

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1393-2022

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