The Recall Desk

FDA (Devices) recall action 80299

Arrow International Inc recalled 4 products on 2018-07-18

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2018-07-18
Critical
0
Units
8,280

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • ModerateFDA (Devices)··2018-07-18

    Arrow International Recalls VPS Rhythm ECG Accessory Packs Due to Labeling Issues

    Arrow International is recalling 2,070 VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    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
    Category
    Distribution
    22 states
  • ModerateFDA (Devices)··2018-07-18

    Arrow International Recalls VPS Rhythm ECG Accessory Packs for Labeling Issues

    Arrow International Inc. is recalling 2,070 units of VPS Rhythm ECG Accessory Packs because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    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 V
    Category
    Distribution
    22 states
  • LowFDA (Devices)··2018-07-18

    Arrow International Recalls VPS TipTracker Stylet Accessory Due to Labeling Issues

    Arrow International Inc. is recalling 2,070 units of the VPS TipTracker Stylet Accessory because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    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). T
    Category
    Distribution
    22 states
  • ModerateFDA (Devices)··2018-07-18

    Arrow International Recalls Midline Catheter Kits Due to Labeling Issues

    Arrow International is recalling 2,070 Peripherally Inserted Midline Catheter Kits because the product pouch label may not easily identify the lot number, expiration date, and associated symbols.

    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 th
    Category
    Distribution
    22 states