Bioseal Corporation Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile EO, UDI: (01)00630094430157
Brand
Bioseal Corporation
Lot Codes / Batch Numbers
Affected Lot Numbers: 400530 400528, 400536, 400537, 400514, 400522, 400514, 400514, 400522, 400514, 400569, 400569, 400565, 400569, 400565, 400556, 400556, 400556, 400540, 400562, 400537, 400530, 400537, 400530, 400537
Products Sold
Affected Lot Numbers: 400530 400528, 400536, 400537, 400514, 400522, 400514, 400514, 400522, 400514, 400569, 400569, 400565, 400569, 400565, 400556, 400556, 400556, 400540, 400562, 400537, 400530, 400537, 400530, 400537
Bioseal Corporation is recalling Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC015/20, Sterile E due to Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 recalls@biosealnet.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, MO
Page updated: Jan 10, 2026