Recall Z-1624-2021
Bioseal Corporation · initiated March 23, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only, UDI: (01)00630094430096
Codes / lots: Affected Lot Numbers: 400521, 400514, 400551, 400556, 400551, 400541, 400536, 400536, 400536 400536, 400536, 400556, 400558
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-1624-2021
- Initiated
- March 23, 2021
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Quantity
- 580 units
- Distribution
- US: IL and MO OUS: None
- Recalling firm
- Bioseal Corporation, Placentia, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1622-2021 Class II | Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF:…Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus… | 03/23/2021Completed |
| Z-1623-2021 Class II | Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF:…Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus… | 03/23/2021Completed |