Device recall: Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA
Class II FDA enforcement event 82865. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lidstock states the incorrect expiration date for the product
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Arrow International Inc started this device recall on 23 Apr 2019. The firm address in the FDA record is in Reading, PA. FDA put the recall in Class II. FDA event 82865 has 36 product records. The first FDA enforcement report date is 26 Jun 2019. The record gives the status Terminated, with the termination date 13 Jan 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Foreign:
Recalling firm
Arrow International Inc, Reading, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
36 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1787-2019 | Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA | 66 units | Class II | Terminated | 26 Jun 2019 |
| Z-1788-2019 | Arrow PICC Kit Product Code: ASK 45541 LVH1 | 105 units | Class II | Terminated | 26 Jun 2019 |
| Z-1789-2019 | Arrow PICC Kit Product Code: ASK 45541 RWJ4 | 100 units | Class II | Terminated | 26 Jun 2019 |
| Z-1790-2019 | Arrow PICC Kit pre loaded with Arrow VPS Precision Stylet Product Code: ASK 45552 CRM | 190 units | Class II | Terminated | 26 Jun 2019 |
| Z-1791-2019 | Arrow PICC Kit Product Code: ASK 45552 RWJ4 | 1840 units | Class II | Terminated | 26 Jun 2019 |
| Z-1792-2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A | 180 units | Class II | Terminated | 26 Jun 2019 |
| Z-1793-2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A | 108 units | Class II | Terminated | 26 Jun 2019 |
| Z-1794-2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45052 HPK1A | 185 units | Class II | Terminated | 26 Jun 2019 |
| Z-1795-2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45541 HPK1A | 20 units | Class II | Terminated | 26 Jun 2019 |
| Z-1796-2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDA 45552 VPS2 | 159 units | Class II | Terminated | 26 Jun 2019 |
| Z-1797-2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A | 78 units | Class II | Terminated | 26 Jun 2019 |
| Z-1798-2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A | 77 units | Class II | Terminated | 26 Jun 2019 |
| Z-1799-2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A | 96 units | Class II | Terminated | 26 Jun 2019 |
| Z-1800-2019 | Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A | 84 units | Class II | Terminated | 26 Jun 2019 |
| Z-1801-2019 | Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A | 174 units | Class II | Terminated | 26 Jun 2019 |
| Z-1802-2019 | Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A | 6 units | Class II | Terminated | 26 Jun 2019 |
| Z-1803-2019 | Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42563 JX1A | 191 units | Class II | Terminated | 26 Jun 2019 |
| Z-1804-2019 | Arrow JACC with Chlorag+ard Technology Jugular Axillosubclavian Central Catheter Product Code: CDC 43063 JX1A | 12 units | Class II | Terminated | 26 Jun 2019 |
| Z-1805-2019 | Arrow PICC with Chlorag+ard Technology Product Code: CDC 44052 HPK1A | 135 units | Class II | Terminated | 26 Jun 2019 |
| Z-1806-2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44052 VPS2 | 162 units | Class II | Terminated | 26 Jun 2019 |
| Z-1807-2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44063 VPS2 | 48 units | Class II | Terminated | 26 Jun 2019 |
| Z-1808-2019 | Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45041 VPS2 | N/A | Class II | Terminated | 26 Jun 2019 |
| Z-1809-2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 HPK1A | 350 units | Class II | Terminated | 26 Jun 2019 |
| Z-1810-2019 | Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 45063 VPS2 | 279 units | Class II | Terminated | 26 Jun 2019 |
| Z-1811-2019 | Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A | 450 units | Class II | Terminated | 26 Jun 2019 |
| Z-1812-2019 | Arrow JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM | 2 units | Class II | Terminated | 26 Jun 2019 |
| Z-1813-2019 | Arrow JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM | 9 units | Class II | Terminated | 26 Jun 2019 |
| Z-1814-2019 | Arrow JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM | 1 unit | Class II | Terminated | 26 Jun 2019 |
| Z-1815-2019 | Arrow JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM | 3 units | Class II | Terminated | 26 Jun 2019 |
| Z-1816-2019 | Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM | 16 units | Class II | Terminated | 26 Jun 2019 |
| Z-1817-2019 | Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM | 52 units | Class II | Terminated | 26 Jun 2019 |
| Z-1818-2019 | Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS | 430 units | Class II | Terminated | 26 Jun 2019 |
| Z-1819-2019 | Arrow PICC with Chlorag+ard Technology Product Code: PR 45541 HPHNL | 983 units | Class II | Terminated | 26 Jun 2019 |
| Z-1820-2019 | Arrow PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM | 991 units | Class II | Terminated | 26 Jun 2019 |
| Z-1821-2019 | Arrow PICC with Chlorag+ard Technology Product Code: PR 45552 HPHNL | 578 units | Class II | Terminated | 26 Jun 2019 |
| Z-1822-2019 | Arrow PICC with Chlorag+ard Technology Product Code:PR 45552 HPHNM | 4345 units | Class II | Terminated | 26 Jun 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 36Median of the firm: 1
- Events of the firm on the register
- 93
Other events of the firm
Official channels
- FDA enforcement report Z-1787-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 82865. https://recallregister.com/fda/ii/82865/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Foreign:
- What quantity of product is in FDA event 82865?
- The event has 36 product records. The first record gives this quantity:
66 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.