Z-2212-2018Class II

RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582

Name: Z-2212-2018 RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2018-05-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-05-10 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582 on 2018-05-10. FDA classified it as Class II and gives the reason as "A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2212-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Posted: 2018-06-14
Terminated: 2020-05-13
Recalling firm: Boston Scientific Corporation
Product: RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Urgent Medical Device Recall letters were sent to customers on 5/10/18. The letters instructed customers to do the following: IMMEDIATELY Stop using the product subject to recall. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). Segregate this product in a secure location for return to AngioDynamics, Inc. Forward a copy of this recall notification to all sites to which you have distributed affected product. Complete and return the Reply Verification Tracking Form. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product.
Quantity in commerce: 13 boxes
Distribution: The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
Product codes and lots: UPN: H96560M1815821; Lot: 5299859

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2212-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2188-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2189-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2190-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2191-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2192-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2193-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2194-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2195-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2196-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2197-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2198-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2199-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2200-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2201-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2202-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2203-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2204-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2205-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2206-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2207-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2208-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2209-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2210-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2211-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2212-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2213-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2214-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2215-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2216-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2217-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2218-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2219-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2220-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2221-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2222-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2223-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2224-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14
Z-2225-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-14

Product code LJS

K152409Class IIXcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc. / cleared 2015-09-24

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)