Z-2254-2013Class II

POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the...

Name: Z-2254-2013 POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the...
Creator: Access Scientific Inc
Published: 2013-08-16
License: https://open.fda.gov/license/

Access Scientific, Inc. / initiated 2013-08-16 / Terminated / root cause: labeling and UDI

FDA source

Access Scientific Inc began a recall of POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids... on 2013-08-16. FDA classified it as Class II and gives the reason as "Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled". 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-2254-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-16
Posted: 2013-09-18
Terminated: 2013-09-24
Recalling firm: Access Scientific, Inc.
Product: POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
Product code: DYB Introducer, Catheter
Reason for recall: Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 8/16/13, Access Scientific visited 2 consignees and initiated a field correction. This is the communication given to the two(2) accounts by our field personnel: "Access Scientific has inadvertently shipped mislabeled devices to your facility. The products affected were 5 Fr. POWERWANDs, Catalog # 92006, lot # I666473." The consignees were instructed to "Quarantine the devices until Access Scientific personnel arrived with the appropriate labeling and performed the corrective action of applying the correct labels to the devices and inserting the DFU into the boxes."
Quantity in commerce: 160 units
Distribution: Distributed in MI and TX.
Product codes and lots: Lot no. I666473

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2254-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2254-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18

Product code DYB

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)