Z-2550-2020Class III

POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C...

Name: Z-2550-2020 POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C...
Creator: Access Scientific LLC
Published: 2020-06-15
License: https://open.fda.gov/license/

Access Scientific, Inc. / initiated 2020-06-15 / Terminated / root cause: labeling and UDI

FDA source

Access Scientific LLC began a recall of POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device... on 2020-06-15. FDA classified it as Class III and gives the reason as "Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2550-2020
Classification: Class III
Status: Terminated
Initiated: 2020-06-15
Posted: 2020-07-10
Terminated: 2024-10-30
Recalling firm: Access Scientific, Inc.
Product: POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media up to a rate 8ml/sec, at a maximum of 325 psi fluid pressure.
Product code: OWL Peripheral Catheter Insertion Kit
Reason for recall: Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user dissatisfaction or annoyance.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 06/15/2020, the firm notified affected customers via email and/or overnight mail of "URGENT: MEDICAL DEVICE RECALL" letter indicating the following: Immediately examine your inventory and quarantine product subject to correction. In addition, if you may have further distributed this product, please identify your customers and notify them a once of this product correction. Your notification to you customers may be enhanced by including a copy of this notification letter. Please take the following actions: 1. Review your inventory for the catalog and lot numbers specified in this notification and quarantine the product as appropriate. 2. You may continue to use the product specified in this notification with the understanding of the errors detailed in this notification, OR 3. Return the product specified in this notification for replacement product. 4. Complete and return the enclosed Recall Response Form as soon as possible. 5. If you choose to return the product, the firm will provide a prepaid shipping label for the return of affected product upon receipt of the Recall Response Form. 6. Report any adverse health consequences experienced with the use of this product to the firm. Events may also be reported to the Food and Drug Admirations MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions regarding this recall, please contact the firm's Senior Manager, Quality and Regulatory Affairs, via email or call 858-259-8333.
Quantity in commerce: 1710
Distribution: US Nationwide distribution including in the state of NY.
Product codes and lots: Lot number 269939, 270552, 270874, and 272261.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2550-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2550-2020	Class III	Terminated	Voluntary: Firm initiated	2020-07-22	2020-07-10

Product code OWL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)