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SONOBLOCK
Pajunk GmbH Medizintechnologie · Model 001280-95 · UDI-DI 04048223051627
10
510(k) clearances
1,308
Adverse events (3 deaths)
17
Recalls
132
Facilities
Description
001280-95
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo |
| 2020-12-08 | Smiths Medical ASD Inc. | The labeling was missing information on sterilization and prohibition of reuse. |
| 2019-12-20 | Arrow International Inc | Product lidstock contains the incorrect expiration date for the product |
| 2019-10-11 | TELEFLEX MEDICAL INC | Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally id |
| 2019-10-11 | TELEFLEX MEDICAL INC | Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally id |
| 2019-08-30 | Pajunk GmbH | Problem with packaging sealing process which affects sterility. |
| 2016-04-22 | Epimed International, Inc. | There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter coul |
| 2015-05-01 | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch |
| 2015-03-30 | Integra LifeSciences Corp. d.b.a. Integra Pain Management | A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles. |
| 2014-04-03 | B. Braun Medical, Inc. | B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.