Arrow International Inc: Product pouch label may not easily identify the lot number, expiration date and associated symbols..

Agency Publication Date: July 8, 2018

Affected Products

Product: VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are trad

Lot Numbers: 13F17A0287 & 13F17C0018

Lot Numbers:

Numbers

Product: VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered

Lot Number: 13F17A0288

Lot Numbers:

Number

Product: VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally conside

Lot Number: 13F17G0074

Lot Numbers:

Number

Product: Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters t

Lot Number: 13F16M0102

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80299

Status: Resolved

Manufacturer: Arrow International Inc

Manufactured In: United States

Units Affected: 4 products (2070 units in total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers: 13F17A0287 & 13F17C0018

Lot Numbers:

Numbers

Lot Number: 13F17A0288

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Number

Lot Number: 13F17G0074

Lot Numbers:

Number

Lot Number: 13F16M0102

Lot Numbers:

Number