Z-0960-2019Class II

PLUS 30 PRIORITY PACK Accessory Kit

Name: Z-0960-2019 PLUS 30 PRIORITY PACK Accessory Kit
Creator: Abbott Vascular
Published: 2018-07-03
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2018-07-03 / Terminated

FDA source

Abbott Vascular began a recall of PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic... on 2018-07-03. FDA classified it as Class II and gives the reason as "Incorrect expiration being entered for one lot". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0960-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-03
Posted: 2019-02-27
Recalling firm: Abbott Vascular
Product: PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Incorrect expiration being entered for one lot.
FDA root cause: Incorrect or no expiration date
Action: Abbott Vascular sent an Urgent Field Safety Notice/ Device Recall letter dated July 3, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: " Review inventory and stop using affected devices. " Complete and return the attached Effectiveness Check Form " Return the unused identified products to Abbott Vascular " Share this notification with other relevant personnel in their organization For questions contact Abbott Representative or Customer Service department on 800-227-9902.
Quantity in commerce: 26 units
Distribution: US Nationwide Distribution - NC and NY
Product codes and lots: Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0960-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0960-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-06	2019-02-26

Product code MAV

K962495Class IIIndeflator Plus 30/Plus 30 Priority Pack9with The.096 Or.115 Rotating Hemostatic Valve)Advanced Cardiovascular Systems, Inc. / cleared 1996-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)