Terumo recalls certain Harvest Graft Delivery Packs (REF 51449) due to potential missing seals on inner pouches. This could lead to contamination during bone graft procedures. Affected units have specific batch numbers and expiration dates.
Certain lots of the Harvest Graft Delivery System GDP-10 Procedure Packs may have a lack of a seal on the inner pouch.
Terumo is recalling certain Harvest Graft Delivery Packs (REF 51449) because some units may have missing seals on the inner pouch. This could cause contamination during bone graft procedures, which are critical for medical treatments.
The inner pouch seal may be missing, which could allow contamination of the bone graft material during surgery. This poses a risk of infection or improper healing if the graft material is not sterile.
Surgical patients and medical professionals using the Harvest Graft Delivery System for bone graft procedures. Those with specific batch numbers and expiration dates listed in the recall are most at risk.
Check for the batch numbers: 04A9925 (exp. 01MAR2018), 05A9928 (exp. 01MAY2019), 06A9948 (exp. 01JUN2019), 06A9978 (exp. 01JUN2019), or 08A9950 (exp. 01AUG2019). The product is a sterile, disposable pack used for bone graft procedures.
Look for the batch numbers listed in the recall: 04A9925, 05A9928, 06A9948, 06A9978, or 08A9950.
It's a sterile, disposable pack that takes cell concentrate from BMAC Procedure Packs and hydrates bone graft material for surgical application.
Batch numbers 04A9925 (exp. 01MAR2018), 05A9928 (exp. 01MAY2019), 06A9948 (exp. 01JUN2019), 06A9978 (exp. 01JUN2019), and 08A9950 (exp. 01AUG2019).
The recall does not require stopping use; it only asks to check for affected batch numbers.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-0075-2018 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-0075-2018 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
