Food, drugs, devices › Vygon U.S.A.
Device recall: PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
FDA enforcement event 79752 is a device recall by Vygon U.S.A. of Lansdale, PA, initiated 28 Feb 2018 and classified Class II, with 8 product records.
FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 19 Feb 2019. Initiation: voluntary: firm initiated. Vygon U.S.A. has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Vygon U.S.A., Lansdale, PA.
Reason for recall
"Potential friction holes may affect the sterility of the product."
Distribution
"Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1633-2018 | PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system. | 16520 total products | Class II | Terminated | 16 May 2018 |
| Z-1634-2018 | Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system. | 16520 total products | Class II | Terminated | 16 May 2018 |
| Z-1635-2018 | Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system. | 16520 total products | Class II | Terminated | 16 May 2018 |
| Z-1636-2018 | Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system. | 16520 total products | Class II | Terminated | 16 May 2018 |
| Z-1637-2018 | PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system. | 16520 total products | Class II | Terminated | 16 May 2018 |
| Z-1638-2018 | Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system. | 16,520 total products | Class II | Terminated | 16 May 2018 |
| Z-1639-2018 | PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system. | 16,520 total products | Class II | Terminated | 16 May 2018 |
| Z-1640-2018 | PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system. | 16,520 total products | Class II | Terminated | 16 May 2018 |
Context
Other enforcement events for Vygon U.S.A.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Apr 2021 | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. | Device | Class II | 1 |
| 6 Dec 2018 | Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular li | Device | Class II | 2 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential friction holes may affect the sterility of the product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Feb 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.