Z-1624-2021Class II

Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single...

Name: Z-1624-2021 Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single...
Creator: Bioseal Corporation
Published: 2021-03-23
License: https://open.fda.gov/license/

Bioseal / initiated 2021-03-23 / Completed / root cause: packaging

FDA source

Bioseal Corporation began a recall of Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096 on 2021-03-23. FDA classified it as Class II and gives the reason as "Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1624-2021
Classification: Class II
Status: Completed
Initiated: 2021-03-23
Posted: 2021-05-20
Recalling firm: Bioseal
Product: Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Product code: KDD Kit, Surgical Instrument, Disposable
Reason for recall: Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: On 3/23/21, Bioseal emailed an "Urgent: Medical Device Recall" notice to affected consignees. In addition to informing consignees about the recall the firm ask consignees to take the following actions: 1. Please discontinue use of the product listed above. 2. Please complete enclosed response form listing the quantity of affected product on hand via email to [email protected]. Even if you do not have the affected product please complete and return the form. Once we have received the completed form we will forward product return information, if applicable. 3. If you have transferred possession of the product to another organization, you are required by FDA regulations to notify them of this recall communication. Please have any affected product returned to you for collection and return to Bioseal as specified above. 4. Adverse reactions or quality problems experience with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program. 5. If you have any questions regarding this matter, please contact customer service at 800-441-7325, Monday-Friday 8:00 AM - 5:00 PM P.S.T.
Quantity in commerce: 580 units
Distribution: US: IL and MO OUS: None
Product codes and lots: Affected Lot Numbers: 400521, 400514, 400551, 400556, 400551, 400541, 400536, 400536, 400536 400536, 400536, 400556, 400558

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1624-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1622-2021	Class II	Completed	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1623-2021	Class II	Completed	Voluntary: Firm initiated	2021-05-26	2021-05-20
Z-1624-2021	Class II	Completed	Voluntary: Firm initiated	2021-05-26	2021-05-20

Product code KDD

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)