Recall events
/
Event 79752
Event summary
Timeline bucket February 28, 2018
Product types Device
Classifications Class II
Statuses Terminated
Recalling firm wording Vygon U.S.A.
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
8 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 8
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
Z-1633-2018
Recall number Z-1633-2018
Initiated February 28, 2018
Classification Class II
Status Terminated
Quantity 16520 total products
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential friction holes may affect the sterility of the product.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1633-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9493]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential friction holes may affect the sterility of the product.
Code information Lot Number: 17B012D UDI: 08498840009802
Distribution pattern Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26215]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 8
Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
Z-1634-2018
Recall number Z-1634-2018
Initiated February 28, 2018
Classification Class II
Status Terminated
Quantity 16520 total products
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential friction holes may affect the sterility of the product.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1634-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51460]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential friction holes may affect the sterility of the product.
Code information Lot Number: 17C060D UDI: 08498840010563
Distribution pattern Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[21607]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 8
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Z-1635-2018
Recall number Z-1635-2018
Initiated February 28, 2018
Classification Class II
Status Terminated
Quantity 16520 total products
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential friction holes may affect the sterility of the product.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1635-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[51438]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential friction holes may affect the sterility of the product.
Code information Lot Number: 17I024D UDI: 08498840010068
Distribution pattern Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[21441]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 8
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Z-1636-2018
Recall number Z-1636-2018
Initiated February 28, 2018
Classification Class II
Status Terminated
Quantity 16520 total products
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential friction holes may affect the sterility of the product.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1636-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[3889]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential friction holes may affect the sterility of the product.
Code information Lot Numbers: 17F001D & 17K038D UDI: 08498840004814
Distribution pattern Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26889]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 8
PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Z-1637-2018
Recall number Z-1637-2018
Initiated February 28, 2018
Classification Class II
Status Terminated
Quantity 16520 total products
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential friction holes may affect the sterility of the product.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1637-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[26891]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential friction holes may affect the sterility of the product.
Code information Lot Numbers: 16I026D & 16J032D UDI: 08498840004784
Distribution pattern Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26120]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 8
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Z-1638-2018
Recall number Z-1638-2018
Initiated February 28, 2018
Classification Class II
Status Terminated
Quantity 16,520 total products
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential friction holes may affect the sterility of the product.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1638-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16049]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential friction holes may affect the sterility of the product.
Code information Lot Numbers: 16I025D, 16L026D, 17C014D UDI: 08498840009604
Distribution pattern Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26854]
FDA event record
· Exact recall-number query on openFDA
device · product 7 of 8
PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
Z-1639-2018
Recall number Z-1639-2018
Initiated February 28, 2018
Classification Class II
Status Terminated
Quantity 16,520 total products
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential friction holes may affect the sterility of the product.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1639-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16044]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential friction holes may affect the sterility of the product.
Code information Lot Numbers: 16I024D, 16H009D, 16I019D, 16J018D, 16L002D, 16L058D, 17B001D, 17B031D, 17C009D, 17C050D, 17F031D, 17F033D, 17H048D, 17F034D, 17H041D, UDI: 08498840009765
Distribution pattern Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20400]
FDA event record
· Exact recall-number query on openFDA
device · product 8 of 8
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Z-1640-2018
Recall number Z-1640-2018
Initiated February 28, 2018
Classification Class II
Status Terminated
Quantity 16,520 total products
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Potential friction holes may affect the sterility of the product.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-1640-2018
Source locator 0001-device-recall-0001-of-0001.json.zip#results[9474]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Potential friction holes may affect the sterility of the product.
Code information Lot Numbers: 17I040D, 17I041D, 17J016D, 17I002D, 17J015D, 17J018D, UDI: 08498840010648
Distribution pattern Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[26800]
FDA event record
· Exact recall-number query on openFDA
