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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84653

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 24, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Flowonix Medical Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082

Z-1120-2020
Recall number
Z-1120-2020
Initiated
December 24, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Flowonix Medical Inc
Quantity
6670 (US)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware code may result in the pump not sending the expected error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

Code information

All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10JW4A32 10HW4A29 10JW4A44 10JW4A35 10HW4A45 10JW4A05 10JW4A08 10JW4A46 10JW4A36 10JW4A30 10JW4A39 10JW4A06 10JW4A21 10JW4A01 10JW4A27 10KW4A47 10JW4A29 10JW4A41 10KW4A122 10JW4A02 10KW4A05 10JW4A25 10KW4A38 10KW4A61 10KW4A11 10KW4A16 10KW4A27 10KW4A08 10KW4A117 10KW4A68 10KW4A99 10KW4A91 10KW4A20 10KW4A53 10KW4A106 10KW4A02 10JW4A20 10KW4A35 10KW4A18 10KW4A101 10AX4A21 10JW4A43 10KW4A73 10KW4A123 10KW4A67 10AX4B27 10KW4A31 10KW4A24 10AX4A37 10KW4A83 10AX4A36 10AX4A22 10AX4A10 10KW4A42 10KW4A119 10AX4B24 10KW4A89 10KW4A71 10KW4A116 10AX4A12 10DX4A79 10DX4A10 10AX4B06 10AX4B09 10DX4A95 10AX4A81 10AX4A98 10KW4A103 10AX4A96 10AX4A95 10AX4B82 10AX4A76 10KW4A48 10HY4C42 10KW4A09 10AX4A88 10DX4A32 10AX4A87 10AX4B92 10GX4B05 10GX4A30 10KW4A104 10AX4A14 10DX4A98 10GX4B21 10AX4A85 10KW4A85 10KW4A06 10AX4A73 10GX4A21 10GX4A09 10DX4A85 10GX4A82 10JW4A31 10GX4A87 10JW4A16 10GX4A85 10KW4A12 10GX4B16 10KW4A43 10GX4A34 10GX4A83 10AX4B78 10GX4B03 10GX4A38 10GX4B08 10KW4A29 10GX4B07 10KW4A30 10GX4A32 10AX4B90 10GX4A70 10AX4B81 10AX4B53 10GX4A92 10KY4A20 10KW4A52 10KW4A39 10GX4A19 10GX4A96 10DX4A21 10KX4A02 10DX4B07 10KX4A12 10KX4A15 10KW4A75 10GX4A99 10KX4A43 10GX4A45 10KX4A40 10KX4A41 10DX4A09 10DX4A74 10DX4A48 10KX4A42 10GX4A97 10GX4A10 10AX4B80 10KX4A59 10JW4A04 10KW4A44 10GX4A73 10KX4A14 10KX4A13 10GX4B15 10KX4A70 10KX4A57 10KX4A74 10KW4A25 10GX4A03 10GX4A63 10GX4A71 10KW4A108 10KX4A85 10KW4A105 10GX4A40 10GX4A14 10DX4A33 10BY4A40 10BY4A51 10BY4A39 10KX4A62 10BY4A25 10BY4A59 10BY4A36 10EY4A53 10KX4A10 10KX4A39 10EY4A27 10KX4A26 10EY4A26 10BY4A60 10EY4A38 10KX4A80 10BY4A57 10EY4A17 10EY4A83 10EY4A03 10BY4A48 10EY4A25 10EY4A29 10EY4A88 10EY4A99 10EY4A59 10EY4A05 10EY4A82 10EY4A19 10EY4A67 10EY4A89 10BY4A52 10KX4A17 10EY4A36 10EY4A58 10EY4A73 10EY4A43 10GX4A12 10KX4A78 10EY4A15 10BY4A34 10GY4A63 10EY4A37 10EY4A98 10KX4A25 10BY4A30 10GY4A16 10EY4A48 10KX4A76 10GY4A11 10GY4A19 10GY4A60 10GY4A55 10GY4A50 10GY4A49 10GY4A54 10BY4A31 10EY4A72 10KX4A11 10GY4A66 10GY4A40 10GY4A18 10EY4A94 10GY4A32 10EY4A13 10EY4A46 10GY4A72 10GY4A20 10GY4A06 10KX4A27 10KX4A08 10GY4A45 10KX4A30 10GY4A25 10KX4A32 10BY4A42 10GY4A15 10HY4B20 10GY4A35 10GY4A12 10GY4A58 10HY4B44 10GY4A23 10HY4B29 10GY4A21 10GY4A31 10GY4A53 10HY4B18 10KX4A29 10GY4A52 10HY4B16 10HY4B42 10HY4A97 10GY4A74 10HY4B48 10GY4A34 10HY4B41 10HY4B03 10EY4A76 10GY4A26 10HY4B23 10HY4B40 10HY4B25 10HY4B37 10HY4B55 10HY4B02 10HY4A85 10HY4B22 10HY4B54 10HY4B07 10HY4B80 10HY4B26 10HY4A78 10HY4C29 10HY4C11 10GY4A52¿ 10GX4B14 10KY4A41 10KX4A71 10GX4B02 10AX4B85 10HY4C03 10HY4B86 10HY4C16 10HY4C46 10HY4C34 10HY4B17 10HY4B65 10HY4B30 10HY4B62 10HY4B56 10HY4C35 10HY4B33 10HY4A81 10HY4C13 10HY4B10 10HY4C07 10HY4C27 10HY4C12 10HY4B96 10HY4B76 10HY4B24 10HY4C08 10HY4C39 10HY4C06 10HY4B83 10HY4C30 10HY4C36 10IY4A46 10HY4C40 10HY4B70 10IY4A29 10HY4C01 10HY4A98 10HY4B08 10IY4A17 10HY4C47 10HY4C32 10HY4C26 10IY4A38 10IY4A25 10HY4A80 10IY4A37 10IY4A43 10HY4C41 10IY4A51 10IY4A19 10IY4A33 10HY4B91 10HY4B51 10JY4A10 10KY4A60 10KY4A93 10KY4A15 10JY4A15 10KY4A21 10IY4A27 10IY4A13 10JY4A18 10JY4A07 10KY4A71 10KY4A39 10KY4A06 10HY4B97 10KY4A72 10KY4A86 10IY4A54 10KY4A87 10KY4A31 10AZ4A51 10KY4A25 10IY4A28 10KY4A50 10AZ4A35 10AZ4A24 10KY4A91 10AZ4A57 10IY4A31 10KY4A78 10KY4A84 10KY4A03 10KY4A82 10KY4A62 10KY4A44 10KY4A13 10HY4A79 10KY4A69 10AZ4A15 10JY4A28 10KY4A51 10JY4A16 10KY4A36 10AZ4A14 10AZ4A65 10KY4A94 10KY4A64 10KY4A47 10KY4A67 10JY4A03 10HY4A91 10AZ4A54 10HY4C23 10AZ4A08 10KY4A40 10AZ4A31 10BZ4A26 10KY4A79 10IY4A04 10EY4A60 10HY4B90 10KY4A90 10EY4A40 10KY4A30 10IY4A02 10AZ4A22

Distribution pattern

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

device · product 2 of 6

Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228

Z-1121-2020
Recall number
Z-1121-2020
Initiated
December 24, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Flowonix Medical Inc
Quantity
6670 (US)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware code may result in the pump not sending the expected error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

Code information

All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A31 10AZ4A69X 10AZ4A07X 10BZ4A16X 10BZ4A61X 10BZ4A41X 10AZ4A48X 10AZ4A50X 10AZ4A23X 10AZ4A36X 10AZ4A42X 10BZ4A37X 10BZ4A64X 10BZ4A12X 10CZ4B09X 10CZ4A95X 10CZ4B22X 10BZ4A18X 10CZ4A79X 10CZ4A86X 10CZ4A96X 10CZ4A88X 10CZ4A80X 10CZ4A85X 10CZ4A81X 10CZ4A82X 10CZ4A78X 10CZ4A91X 10CZ4A94X 10CZ4A90X 10CZ4A77X 10CZ4B28X 10CZ4B05X 10CZ4B15X 10CZ4B21X 10CZ4A87X 10CZ4B32X 10AZ4A41X 10CZ4B23X 10CZ4A93X 10CZ4B01X 10CZ4B17X 10CZ4B04X 10CZ4B30X 10BZ4A55X 10CZ4B08X 10CZ4A76X 10CZ4B33X 10CZ4B20X 10DZ4A01X 10DZ4A58X 10DZ4A19X 10CZ4B36X 10CZ4A84X 10DZ4A18X 10CZ4B24X 10DZ4A76X 10BZ4A30X 10CZ4B26X 10BZ4A09X 10DZ4A51X 10DZ4A93X 10DZ4A32X 10CZ4B03X 10DZ4A89X 10BZ4A11X 10DZ4A30X 10CZ4B25X 10DZ4A65X 10DZ4A05X 10DZ4A98X 10DZ4A08X 10DZ4A42X 10DZ4A77X 10CZ4A92X 10DZ4A35X 10DZ4A80X 10DZ4A92X 10DZ4A88X 10DZ4A07X 10BZ4A39X 10DZ4A73X 10DZ4A53X 10DZ4A28X 10DZ4A84X 10DZ4A45X 10CZ4B14X 10DZ4A40X 10DZ4A72X 10DZ4A64X 10DZ4A79X 10DZ4A60X 10DZ4A82X 10DZ4A37X 10DZ4B39X 10DZ4A54X 10DZ4A67X 10CZ4B29X 10BZ4A59X 10DZ4A20X 10DZ4A38X 10DZ4B04X 10DZ4A36X 10DZ4A91X 10DZ4B37X 10DZ4B06X 10DZ4A34X 10DZ4A25X 10DZ4B24X 10DZ4B49X 10DZ4B38X 10CZ4A89X 10DZ4B05X 10DZ4A15X 10DZ4A43X 10DZ4B54X 10BZ4A25X 10DZ4A66X 10DZ4B53X 10DZ4A29X 10DZ4A23X 10DZ4B08X 10DZ4A21X 10DZ4B40X 10DZ4A83X 10DZ4A17X 10DZ4A62X 10DZ4B19X 10DZ4B46X 10EZ4A36X 10DZ4B16X 10DZ4A87X 10DZ4B25X 10DZ4B43X 10DZ4B10X 10DZ4B61X 10DZ4B50X 10DZ4B07X 10DZ4B48X 10DZ4B26X 10DZ4B29X 10DZ4A27X 10CZ4B27X 10EZ4A02X 10DZ4B22X 10DZ4B15X 10EZ4A46X 10EZ4A27X 10EZ4A01X 10DZ4A47X 10DZ4A81X 10DZ4A33X 10EZ4A30X 10EZ4A26X 10EZ4A51X 10DZ4B03X 10EZ4A37X 10EZ4A13X 10EZ4A39X 10EZ4A35X 10DZ4B45X 10EZ4A28X 10DZ4A10X 10FZ4A34X 10CZ4B35X 10EZ4A09X 10EZ4A43X 10EZ4A05X 10EZ4A17X 10EZ4A16X 10DZ4B21X 10DZ4A94X 10EZ4A19X 10EZ4A45X 10DZ4A44X 10DZ4A68X 10EZ4A25X 10FZ4A29X 10EZ4A32X 10DZ4A48X 10FZ4A24X 10EZ4A18X 10DZ4B55X 10DZ4A06X 10FZ4A02X 10EZ4A57X 10EZ4A24X 10EZ4A58X 10EZ4A06X 10FZ4A38X 10FZ4A03X 10EZ4A29X 10EZ4A08X 10EZ4A55X 10FZ4A36X 10EZ4A20X 10EZ4A31X 10DZ4B18X 10GZ4A40X 10FZ4A18X 10FZ4A39X 10DZ4B42X 10FZ4A31X 10EZ4A47X 10GZ4A44X 10GZ4A58X 10DZ4B51X 10GZ4A27X 10DZ4B30X 10FZ4A37X 10GZ4A01X 10GZ4A43X 10GZ4A38X 10GZ4A35X 10EZ4A48X 10GZ4A03X 10GZ4A08X 10GZ4A37X 10DZ4B41X 10GZ4A02X 10DZ4B31X 10DZ4A55X 10GZ4A76X 10GZ4A66X 10DZ4B20X 10FZ4A15X 10FZ4A01X 10GZ4A34X 10EZ4A10X 10FZ4A22X 10GZ4A73X 10EZ4A53X 10FZ4A21X 10GZ4A94X 10GZ4A06X 10GZ4A61X 10GZ4A78X 10EZ4A60X 10FZ4A13X 10GZ4A96X 10GZ4A04X 10FZ4A28X 10GZ4A11X 10EZ4A34X 10GZ4A59X 10EZ4A11X 10GZ4A05X 10FZ4A04X 10GZ4A18X 10EZ4A49X 10GZ4A54X 10GZ4A92X 10GZ4A90X 10GZ4A57X 10EZ4A40X 10FZ4A40X 10GZ4A63X 10DZ4A49X 10GZ4A41X 10GZ4A29X 10GZ4A83X 10GZ4B54X 10GZ4A70X 10GZ4A19X 10EZ4A23X 10FZ4A06X 10GZ4A95X 10FZ4A20X 10GZ4A30X 10GZ4A89X 10GZ4A72X 10GZ4A71X 10GZ4A12X 10GZ4B34X 10GZ4B18X 10GZ4A09X 10GZ4B22X 10GZ4A99X 10GZ4A93X 10GZ4A64X 10GZ4A77X 10FZ4A05X 10DZ4A59X 10GZ4A75X 10GZ4A98X 10GZ4B26X 10GZ4A33X 10GZ4B08X 10FZ4A32X 10GZ4B59X 10GZ4B38X 10GZ4B07X 10GZ4B44X 10GZ4B41X 10GZ4A69X 10GZ4A87X 10HZ4A02X 10GZ4B55X 10GZ4B28X 10HZ4A26X 10GZ4A91X 10HZ4A41X 10GZ4B52X 10HZ4A46X 10FZ4A35X 10GZ4B16X 10FZ4A09X 10HZ4A70X 10DZ4A12X 10GZ4B37X 10GZ4A42X 10DZ4B35X 10GZ4A20X 10HZ4A82X 10HZ4A49X 10GZ4A97X 10EZ4A59X 10HZ4A16X 10GZ4A21X 10GZ4A53X 10HZ4A07X 10HZ4A33X 10HZ4A81X 10GZ4B06X 10HZ4A19X 10HZ4A22X 10HZ4A83X 10HZ4A20X 10HZ4A21X 10HZ4A12X 10HZ4A04X 10DZ4B12X 10GZ4A07X 10HZ4A15X 10GZ4B01X 10HZ4A80X 10GZ4A46X 10HZ4A35X 10HZ4A39X 10GZ4B51X 10GZ4B12X 10HZ4A09X 10HZ4A57X 10GZ4B32X 10GZ4B57X 10HZ4A71X 10GZ4B10X 10HZ4A25X 10FZ4A07X 10GZ4B11X 10HZ4A64X 10IZ4B09X 10GZ4A81X 10GZ4B21X 10GZ4B53X 10IZ4A84X 10HZ4A11X 10JZ4A67X 10HZ4A05X 10HZ4A37X 10IZ4A64X 10GZ4B36X 10IZ4A38X 10GZ4B04X 10GZ4B35X 10HZ4A61X 10HZ4A28X 10HZ4A44X 10HZ4A23X 10IZ4A78X 10GZ4B61X 10GZ4A39X 10IZ4A91X 10HZ4A40X 10IZ4B05X 10IZ4A60X 10IZ4B14X 10IZ4A61X 10GZ4B25X 10GZ4B47X 10IZ4A92X 10IZ4B08X 10IZ4B07X 10HZ4A55X 10GZ4B45X 10GZ4B42X 10HZ4A69X 10IZ4A50X 10IZ4A85X 10GZ4A15X 10IZ4B17X 10HZ4A42X 10CZ4B06X 10HZ4A53X 10IZ4A79X 10HZ4A24X 10IZ4A69X 10IZ4A42X 10IZ4A96X 10IZ4A72X 10HZ4A17X 10IZ4B21X 10IZ4A73X 10IZ4A74X 10IZ4A31X 10JZ4A18X 10IZ4A77X 10IZ4A49X 10IZ4A57X 10IZ4A35X 10IZ4B16X 10IZ4B15X 10IZ4A46X 10GZ4A10X 10GZ4B03X 10IZ4A71X 10IZ4A43X 10JZ4A05X 10IZ4B06X 10JZ4A60X 10HZ4A45X 10JZ4A35X 10IZ4A40X 10IZ4A34X 10IZ4A93X 10HZ4A85X 10JZ4A11X 10IZ4B04X 10JZ4A54X 10JZ4A56X 10IZ4A67X 10GZ4A36X 10IZ4B01X 10HZ4A08X 10JZ4A12X 10JZ4A27X 10HZ4A56X 10JZ4A46X 10JZ4A78X 10JZ4A23X 10HZ4A79X 10JZ4A02X 10JZ4A89X 10JZ4A19X 10JZ4A82X 10JZ4A44X 10IZ4A76X 10IZ4A53X 10JZ4A90X 10JZ4A81X 10IZ4B12X 10GZ4B15X 10JZ4A80X 10JZ4A06X 10JZ4A53X 10JZ4A87X 10GZ4B60X 10JZ4A88X 10JZ4A17X 10HZ4A31X 10JZ4A72X 10JZ4A01X 10JZ4A16X 10IZ4A75X 10JZ4A07X 10HZ4A03X 10HZ4A54X 10JZ4A39X 10HZ4A13X 10JZ4A29X 10JZ4A65X 10JZ4A63X 10JZ4A69X 10JZ4A32X 10EZ4A22X 10JZ4A37X 10IZ4A66X 10JZ4A62X 10JZ4A34X 10JZ4A43X 10JZ4A42X 10IZ4A83X 10IZ4A59X 10JZ4B16X 10HZ4A34X 10JZ4A08X 10JZ4B17X 10JZ4B25X 10JZ4B10X 10JZ4B08X 10JZ4A13X 10JZ4B02X 10JZ4B24X 10JZ4A95X 10JZ4A25X 10JZ4A64X 10IZ4B13X 10JZ4B12X 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10JB4D68X 10JB4D23X 10KB4A35X 10JB4C39X 10JB4D11X 10JB4D29X 10JB4A58X 10JB4D39X 10JB4B79X 10IB4A62X 10IB4A80X 10JB4D08X 10HB4C15X 10IB4A63X 10KB4A03X 10JB4A50X 10JB4D25X 10JB4A66X 10KB4A62X 10KB4A46X 10JB4A12X 10JB4A38X 10JB4D49X 10KB4A18X 10JB4C13X 10JB4B66X 10KB4A06X 10IB4A77X 10JB4B56X 10JB4D06X 10JB4B92X 10KB4A19X 10JB4D22X 10KB4A40X 10JB4D60X 10JB4D55X 10KB4A78X 10KB4A13X 10JB4D46X 10JB4D77X 10JB4D05X 10JB4D76X 10JB4A20X 10JB4C38X 10KB4A74X 10KB4A38X 10KB4A57X 10KB4A39X 10JB4C98X 10KB4A36X 10JB4B54X 10KB4A07X 10KB4A12X 10JB4D37X 10KB4A47X 10JB4D62X

Distribution pattern

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

device · product 3 of 6

Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242

Z-1122-2020
Recall number
Z-1122-2020
Initiated
December 24, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Flowonix Medical Inc
Quantity
6670 (US)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware code may result in the pump not sending the expected error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

Code information

All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10GC4A24X 10GC4A02X 10GC4A18X 10GC4A22X 10GC4A14X 4MA00044X 4MA00006X 10GC4A12X 10GC4A09X 10GC4A06X 10GC4A21X 4MA00008X 10GC4A01X 10GC4A20X 10GC4A11X 10GC4A16X 10GC4A17X 4MA00045X 4MA00055X 10GC4A08X 4MA00032X 4MA00031X 4MA00010X 4MA00042X

Distribution pattern

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

device · product 4 of 6

US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082

Z-1123-2020
Recall number
Z-1123-2020
Initiated
December 24, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Flowonix Medical Inc
Quantity
6670 (US)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware code may result in the pump not sending the expected error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

Code information

All units with pump firmware version 0.26 manufactured from 2012 until the present time. Serial Numbers 10HW4A57 10AX4A06 36ES4A15 36AR4A04 36AR4A06 36AR4A13 36HS4A10 36HS4A54 36JN4A04 36JN4A06 36JN4A07 36JN4A09 36JN4A13 36JN4A14 36JN4A15 36JN4A18 36JN4A23 36JN4A28 36JN4A35 36KN4A11 36KN4A16 36KN4A23 36KN4A27 36KN4A33 36KN4A34 36KN4A41 36HS4A01 10IT4A21 36HS4A14 36HS4A26 36BS4A17 36ES4A28 36ES4A33 36ES4A08 10IT4A16 36FR4A13 36HS4A61 10ET4A07 36HS4A46 10ET4A20 36HS4A25 36HS4A43 10ET4A02

Distribution pattern

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

device · product 5 of 6

Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)

Z-1124-2020
Recall number
Z-1124-2020
Initiated
December 24, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Flowonix Medical Inc
Quantity
1083 (OUS)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware code may result in the pump not sending the expected error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

Code information

All units with pump firmware version 0.26 manufactured from 2012 until the present time.

Distribution pattern

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.

device · product 6 of 6

Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)

Z-1125-2020
Recall number
Z-1125-2020
Initiated
December 24, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Flowonix Medical Inc
Quantity
1083 (OUS)

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware code may result in the pump not sending the expected error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.

Code information

All units with pump firmware version 0.26 manufactured from 2012 until the present time.

Distribution pattern

Nationwide domestic distribution. Foreign distribution to United Kingdom, Republic of Ireland, Poland, Greece, Italy, Germany, Netherlands, and Belgium.