PuraGel 3mL
3-D MATRIX INC. · Model 651-005 · UDI-DI 00860007400308
Description
PuraGel™ is a space-occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process. PuraGel™ is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period. PuraGel™ is also indicated to adhere to oral tissue and form a protective barrier over the wound to prevent irritation and contamination to manage the pain in all types of oral wounds, mouth sores, injuries, and ulcers of the oral mucosa. It provides a moist wound environment required for optimal wound healing. (3 ml)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
| 2025-02-25 | Stryker Corporation | There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that |
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