Drug recall
Pedi-Pak Quad 75 mL Transfer Pack - Needless 'Y" site Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack…
FDA recall event 68865 · Class III · Genesis BPS, LLC.
Key facts
| Event ID | 68865 |
|---|---|
| Recall numbers | B-0986-14, B-0987-14, B-0988-14, B-0989-14 |
| Recalling firm | Genesis BPS, LLC. |
| Product type | Biologics |
| Products | Pedi-Pak Quad 75 mL Transfer Pack - Needless 'Y" site Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601 TEL:201-708-1408 FAX: 201-708-1104 Genesis BOS International Sarl CP 2361 1260…, Pedi-Pak Quad 75mL Transfer Pack w/o filter Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601 TEL:201-708-1408 FAX: 201-708-1104 Genesis BOS International Sarl CP 2361 1260 Nyon 2…, Pedi-Pak Quad 75mL with In-Line Filter Transfer Pak Rx Only 75 mL Genesis BPS, LLC 65 Commerce, Hackensack, NJ 07601 TEL:201-708-1408 FAX: 201-708-1104 Genesis BOS International Sarl CP 2361 1260 Nyon…, Pedi-Pak Single 75 mL Transfer Bag -Single Rx Only 75 mL Genesis BPS, LLC 65 Commerce Way, Hackensack, NJ 07601 Tel: 201-708-1400 Fax: 201-708-1104 Genesis BPS International Sarl CP 2361 1260 Nyon 2… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Genesis BPS Pedi-Pak Pediatric Transfer Packs, lacking pre-market notification, were distributed. |
| Initiation date | Jul 17, 2014 |
| Report date | Sep 24, 2014 |
| Termination date | Mar 4, 2016 |
| City | Hackensack |
| State | NJ |
| Country | United States |
| FEI number | 1000527169 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: